Lippincott Williams & Wilkins



Supplementary ContenteMethod 1. Inclusion and exclusion criteriaeMethod 2. Operation manual of the fecal immunochemical test (Pupu Tube, New Horizon Health Technology Co., Ltd, Hangzhou, China) used in the TARGET-C trialeMethod 3. Risk factors included in the colorectal cancer risk assessment scoreeTable 1. Participation rates of colonoscopy, fecal immunochemical test (FIT) and risk-adapted screening stratified by age and sexeTable 2. Differences of participation rates by sex and age in different screening groupseTable 3. Compliance of colonoscopy for participants with positive fecal immunochemical test (FIT) results in the FIT and the risk-adapted screening groupseTable 4. Diagnostic yield of the risk-adapted screening group, according to the intention-to-screen analysiseTable 5. Diagnostic yield of colonoscopy, fecal immunochemical test (FIT) and risk-adapted screening, stratified by sex, age and the location of the colorectal lesion, according to the intention-to-screen analysiseTable 6. Detection rate of the risk-adapted screening group, according to the as-screened analysiseTable 7. Detection rate of colonoscopy, fecal immunochemical test (FIT) and risk-adapted screening, stratified by sex, age and the location of the colorectal lesion, according to the as-screened analysiseTable 8. Quality indicators of colonoscopy performed in the colonoscopy, FIT and risk-adapted screening groups.eMethod 1. Inclusion and exclusion criteriaInclusion criteria:Individuals aged 50-74 years living in the study regionAble to sign informed consentExclusion criteria:Prior history of CRC.Prior history of colonic resection.Receipt of any kind of cancer-related therapy (except for non-melanoma skin cancer); prior colonic examination, including colonoscopy, flexible sigmoidoscopy, computed tomography (CT) colonography, and barium enema within 5 years.Prior history of fecal occult blood test and fecal DNA test within 1 year.Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation, including: (i) more than one episode of rectal bleeding within the past 6 months, (ii) documented iron deficiency anemia, and (iii) significant documented unintentional weight loss (>10% of baseline weight) over 6 months.Significant comorbidity that would preclude benefit from screening or pose a significant risk to the performance of colonoscopy (e.g., severe lung disease, end-stage renal disease, end-stage liver disease, severe heart failure, or recent diagnosis of cancer, with the exception of non-melanoma skin cancer.eMethod 2. Operation manual of the fecal immunochemical test (Pupu Tube?, New Horizon Health Technology Co., Ltd) used in the TARGET-C trialeMethod 3. Risk factors included in the colorectal cancer risk assessment scoreBased on previous evidence, we designed the risk score system and detailed information shown in the following Table. Participants with a score ≥4 were defined to be at high risk of colorectal cancer, while those with a score <4 were defined to be at low risk of colorectal cancer.Risk factorCriteriaPointsAge (years)50-54055-64165-742SexFemale0Male1Family history of colorectal cancer among first-degree relativesAbsent0Present1SmokingNon-smoker0Current or past smoker1BMI<230≥231Abbreviations: BMI, Body mass index, calculated as weight (kg)/height2(meters2). eTable 1. Participation rates of colonoscopy, fecal immunochemical test (FIT) and risk-adapted screening stratified by age and sexGroupMen　Women　OverallNuptake/NinvitedRate (95% CI)　Nuptake/NinvitedRate (95% CI)　Nuptake/NinvitedRate (95% CI)(a) colonoscopy group50-59284/62945.2 (41.3-49.1)　517/111846.2 (43.3-49.2)　801/174745.9 (43.5-48.2)60-74431/100243.0 (40.0-46.1)　433/116737.1 (34.4-39.9)　864/216939.8 (37.8-41.9)Total715/163143.8 (41.4-46.3)　950/228541.6 (39.6-43.6)　1665/391642.5 (41.0-44.1)(b) FIT group 　50-591241/130994.8 (93.4-95.9)　2046/214395.5 (94.5-96.3)　3287/345295.2 (94.5-95.9)60-741897/202693.6 (92.5-94.6)　2202/237692.7 (91.6-93.7)　4099/440293.1 (92.3-93.8)Total3138/333594.1 (93.2-94.8)　4248/451994.0 (93.3-94.7)　7386/785494.0 (93.5-94.5)(c) risk-adapted screening group*50-591086/121889.2 (87.3-90.8)　2097/223294.0 (92.9-94.9)　3183/345092.3 (91.3-93.1)60-741273/197064.6 (62.5-66.7)　2172/235692.2 (91.0-93.2)　3445/432679.6 (78.4-80.8)Total2359/318872.4 (75.5-76.9)　4269/458893.0 (92.3-93.7)　6628/777685.2 (84.4-86.0)(d) High-risk individuals in the risk-adapted screening group50-59152/22866.7 (60.3-72.5)　7/1353.8 (29.1-76.8)　159/24166.0 (59.8-71.7)60-74522/116244.9 (42.1-47.8)　43/6962.3 (50.5-72.8)　565/123145.9 (43.1-48.7)Total674/139048.5 (45.9-51.1)　50/8261.0 (50.2-70.8)　724/147249.2 (46.6-51.7)(e) Low-risk individuals in the risk-adapted screening group50-59934/98295.1 (93.6-96.3)　2090/221394.4 (93.4-95.3)　3024/319594.6 (93.8-95.4)60-74751/80393.5 (91.6-95.0)　2129/228193.3 (92.2-94.3)　2880/308493.4 (92.5-94.2)Total1685/178594.4 (93.2-95.4)　4219/449493.9 (93.1-94.5)　5904/627994.0 (93.4-94.6)* 25 participants who did not undergo risk assessment were included.Abbreviations: 95% CI, 95% confidence interval; FIT, fecal immunochemical test.eTable 2. Differences of participation rates by sex and age in different screening groupsStudy groupSubgroupRate (95% CI)Odds ratio (95% CI) *PColonoscopy groupOverall42.5 (41.0-44.1)--SexWomen41.6 (39.6-43.6)Ref.Men43.8 (41.4-46.3)1.08 (0.94-1.24)0.281Age (years)50-5945.9 (43.5-48.2)Ref.60-7439.8 (37.8-41.9)0.82 (0.72-0.94)0.004FIT groupOverall94.0 (93.5-94.5)--SexWomen94.0 (93.3-94.7)Ref.Men94.1 (93.2-94.8)1.07 (0.88-1.30)0.281Age (years)50-5995.2 (94.5-95.9)Ref.60-7493.1 (92.3-93.8)0.75 (0.61-0.92)0.004Risk-adapted screening groupOverall85.2 (84.4-86.0)--SexWomen93.0 (92.3-93.7)Ref.Men72.4 (75.5-76.9)0.20 (0.17-0.23)<0.001Age (years)50-5992.3 (91.3-93.1)Ref.60-7479.6 (78.4-80.8)0.35 (0.30-0.41)<0.001High-risk individuals in the risk-adapted screening groupOverall49.2 (46.6-51.7)--SexWomen61.0 (50.2-70.8)Ref.Men48.5 (45.9-51.1)0.57 (0.35-0.92)0.023Age (years)50-5966.0 (59.8-71.7)Ref.60-7445.9 (43.1-48.7)0.44 (0.32-0.60)<0.001Low-risk individuals in the risk-adapted screening groupOverall94.0 (93.4-94.6)--SexWomen93.9 (93.1-94.5)Ref.Men94.4 (93.2-95.4)1.07 (0.84-1.37)0.591Age (years)50-5994.6 (93.8-95.4)Ref.60-7493.4 (92.5-94.2)0.90 (0.72-1.11)0.324* Logistic regression models including age, sex and study center were used to calculate the odds ratios and 95% confidence intervals.Abbreviations: 95% CI, 95% confidence interval; FIT, fecal immunochemical test.eTable 3. Compliance of colonoscopy for participants with positive fecal immunochemical test (FIT) results in the FIT and the risk-adapted screening groupsGroupNumber ofpositive FITNumber of ColonoscopyRate (%, 95% CI)*Odds ratio(95% CI)P*(a) FIT groupOverall108482776.9 (74.2-79.3)--Sex Women52240974.4 (70.6-77.8)Ref.　 Men56241878.4 (74.6-81.7)1.2 (0.9-1.6)0.194Age (years) 50-5426421380.7 (75.5-85.0)Ref.　 55-5919815678.8 (72.6-83.9)0.9 (0.6-1.5)0.80 60-6427119873.1 (67.5-78.0)0.8 (0.5-1.2)0.26 65-6927520976.0 (70.6-80.7)0.9 (0.6-1.4)0.60 70-74765167.1 (55.9-76.6)0.6 (0.3-1.1)0.10(b) Risk-adapted screening groupOverall79160977.0 (73.9-79.8)--Sex Women22617976.1 (72.4-79.4)Ref.　 Men56543079.2 (73.4-84.0)1.1 (0.7-1.6)0.781Age (years) 50-5424220986.4 (81.5-90.1)Ref.　 55-5917413477.0 (70.2-82.6)0.6 (0.3-0.9)0.03 60-6422216172.5 (66.3-78.0)0.4 (0.3-0.7)<0.001 65-691077570.1 (60.8-77.9)0.4 (0.2-0.8)0.01 70-74463065.2 (50.8-77.3)0.4 (0.2-0.8)0.01*The 95% confidence intervals were calculated using the Wilson’s method.Abbreviations: 95% CI, 95% confidence interval; FIT, fecal immunochemical test. eTable 4. Diagnostic yield of the risk-adapted screening group, according to the intention-to-screen analysisColorectal lesionOverall(N=6446)High-risk subjects (N=724)Low-risk subjects (N=5722)NumberPercent (%)NumberPercent (%)NumberPercent (%)Colorectal cancer130.1740.2790.14Advanced adenoma1161.49745.03420.67Non-advanced adenoma2573.3116511.21921.47Advanced neoplasia1291.66785.30510.81Any neoplasm3864.9624316.511432.28eTable 5. Diagnostic yield of colonoscopy, fecal immunochemical test (FIT) and risk-adapted screening, stratified by sex, age and the location of the colorectal lesion, according to the intention-to-screen analysisColorectal lesionColonoscopy (N=1665)FIT (N=7129)Risk-adapted screening (N=6446)Colonoscopy vs FITColonoscopy vs Risk-adapted screeningRisk-adapted screening vs FITOdds ratio(95% CI)POdds ratio(95% CI)POdds ratio(95% CI)P(a) Men&Colorectal cancer5(0.31)5(0.15)9(0.28)2.02 (0.56-7.29)0.2681.10 (0.34-3.18)0.8691.88 (0.65-6.12)0.260Advanced adenoma51(3.13)57(1.71)98(3.07)1.81 (1.23-2.66)0.0031.00 (0.70-1.41)0.9911.80 (1.29-2.52)<0.001Non-advanced adenoma180(11.04)105(3.15)195(6.12)3.83 (2.98-4.93)<0.0011.93 (1.55-2.39)<0.0011.99 (1.56-2.54)<0.001Advanced neoplasm56(3.43)62(1.86)107(3.36)1.83 (1.26-2.65)0.0011.01 (0.72-1.40)0.9671.81 (1.32-2.50)<0.001Any neoplasm236(14.47)167(5.01)302(9.47)3.25 (2.63-4.02)<0.0011.64 (1.36-1.98)<0.0011.98 (1.62-2.41)<0.001(b) Women&Colorectal cancer4(0.18)2(0.04)4(0.09)3.98 (0.77-28.78)0.1122.03 (0.48-8.58)0.3191.97 (0.39-14.25)0.432Advanced adenoma34(1.49)25(0.55)18(0.39)2.81 (1.67-4.77)<0.0013.96 (2.26-7.19)<0.0010.71 (0.38-1.30)0.271Non-advanced adenoma132(5.78)66(1.46)62(1.35)4.28 (3.18-5.81)<0.0014.68 (3.45-6.41)<0.0010.93 (0.65-1.31)0.666Advanced neoplasm38(1.66)27(0.6)22(0.48)2.90 (1.77-4.81)<0.0013.62 (2.15-6.24)<0.0010.80 (0.45-1.41)0.451Any neoplasm170(7.44)93(2.06)84(1.83)3.99 (3.08-5.19)<0.0014.56 (3.49-6.00)<0.0010.89 (0.66-1.20)0.441(c) 50-59 y#Colorectal cancer3(0.17)1(0.03)6(0.17)5.97 (0.76-120.87)0.1221.00 (0.21-3.80)0.9996.12 (1.04-115.74)0.094Advanced adenoma40(2.29)28(0.81)32(0.93)3.07 (1.89-5.06)<0.0013.65 (1.66-4.29)<0.0011.17 (0.70-1.97)0.549Non-advanced adenoma119(6.81)66(1.91)83(2.41)3.94 (2.90-5.40)<0.0013.16 (2.37-4.24)<0.0011.30 (0.94-1.81)0.12Advanced neoplasm43(2.46)29(0.84)38(1.1)3.18 (1.98-5.18)<0.0012.39 (1.53-3.74)<0.0011.35 (0.83-2.21)0.233Any neoplasm162(9.27)95(2.75)121(3.51)3.90 (3.00-5.09)<0.0013.07 (2.39-3.95)<0.0011.32 (1.00-1.75)0.047(d) 60-74 y#Colorectal cancer6(0.28)6(0.14)7(0.16)2.04 (0.64-6.53)0.2191.67 (0.54-5.04)0.3581.18 (0.39-3.66)0.769Advanced adenoma45(2.07)54(1.23)84(1.94)1.67 (1.11-2.50)0.0121.03 (0.70-1.48)0.8881.60 (1.13-2.27)0.008Non-advanced adenoma193(8.9)105(2.39)174(4.02)4.03 (3.16-5.18)<0.0012.35 (1.89-2.92)<0.0011.73 (1.36-2.23)<0.001Advanced neoplasm51(2.35)60(1.36)91(2.1)1.71 (1.17-2.50)0.0061.08 (0.75-1.53)0.6711.56 (1.12-2.18)0.009Any neoplasm244(11.25)165(3.75)265(6.13)3.32 (2.69-4.09)<0.0011.97 (1.63-2.38)<0.0011.71 (1.39-2.09)<0.001(e) proximal$Colorectal cancer4(0.1)2(0.03)6(0.08)4.07 (0.79-29.40)0.1061.34 (0.34-4.68)0.6543.11 (0.72-21.26)0.165Advanced adenoma42(1.07)36(0.46)44(0.57)2.35 (1.50-3.70)<0.0011.90 (1.24-2.91)0.0031.24 (0.80-1.94)0.337Non-advanced adenoma153(3.91)82(1.04)129(1.66)3.91 (2.99-5.16)<0.0012.44 (1.92-3.11)<0.0011.62 (1.23-2.15)<0.001Advanced neoplasm46(1.17)38(0.48)50(0.64)2.45 (1.59-3.79)<0.0011.83 (1.22-2.75)0.0031.34 (0.88-2.06)0.176Any neoplasm199(5.08)120(1.53)179(2.3)3.52 (2.79-4.44)<0.0012.32 (1.88-2.86)<0.0011.54 (1.22-1.95)<0.001(f) distal$ Colorectal cancer5(0.13)5(0.06)7(0.09)2.02 (0.56-7.29)0.2661.40 (0.41-4.40)0.5661.42 (0.45-4.80)0.55Advanced adenoma52(1.33)58(0.74)83(1.07)1.80 (1.23-2.63)0.0021.22 (0.85-1.73)0.2671.47 (1.05-2.07)0.028Non-advanced adenoma207(5.29)110(1.4)164(2.11)4.02 (3.18-5.11)<0.0012.64 (2.14-3.27)<0.0011.54 (1.20-1.97)<0.001Advanced neoplasm57(1.46)63(0.8)90(1.16)1.82 (1.26-2.62)0.0011.24 (0.88-1.73)0.2181.46 (1.06-2.04)0.022Any neoplasm264(6.74)173(2.2)254(3.27)3.33 (2.73-4.07)<0.0012.20 (1.84-2.64)<0.0011.53 (1.25-1.86)<0.001& The odds ratios and 95% confidence intervals were calculate using the logistic regression models, in which age and study center were additionally adjusted. # The odds ratios and 95% confidence intervals were calculate using the logistic regression models, in which sex and study center were additionally adjusted. $ The odds ratios and 95% confidence intervals were calculate using the logistic regression models, in which age, sex and study center were additionally adjusted.Abbreviation: 95% CI, 95% confidence interval; FIT, fecal immunochemical test.eTable 6. Detection rate of the risk-adapted screening group, according to the as-screened analysisColorectal lesionOverall(N=6446)High-risk subjects (N=724)Low-risk subjects (N=5722)NumberPercent (%)NumberPercent (%)NumberPercent (%)Colorectal cancer130.2040.5590.16Advanced adenoma1161.807410.22420.73Non-advanced adenoma2573.9916522.79921.61Advanced neoplasia1292.007810.77510.89Any neoplasm3865.9924333.561432.50eTable 7. Detection rate of colonoscopy, fecal immunochemical test (FIT) and risk-adapted screening, stratified by sex, age and the location of the colorectal lesion, according to the as-screened analysisColorectal lesionColonoscopy (N=1665)FIT (N=7129)Risk-adapted screening (N=6446)Colonoscopy vs FITColonoscopy vs Risk-adapted screeningRisk-adapted screening vs FITOdds ratio(95% CI)POdds ratio(95% CI)POdds ratio(95% CI)P(a) Men&CRC5(0.70)5(0.17)9(0.39)3.95 (1.08-14.47)0.0331.67 (0.51-4.90)0.3662.47 (0.85-8.10)0.107Advanced adenoma51(7.13)57(1.88)98(4.24)3.49 (2.35-5.18)<0.0011.48 (1.03-2.11)0.0332.35 (1.68-3.30)<0.001Non-advanced adenoma180(25.17)105(3.47)195(8.43)9.05 (6.97-11.81)<0.0013.37 (2.68-4.24)<0.0012.69 (2.11-3.45)<0.001Advanced neoplasm56(7.83)62(2.05)107(4.63)3.56 (2.43-5.20)<0.0011.50 (1.06-2.11)0.022.37 (1.72-3.28)<0.001Any neoplasm236(33.01)167(5.52)302(13.06)8.10 (6.46-10.17)<0.0013.04 (2.47-3.74)<0.0012.72 (2.23-3.33)<0.001(b) Women&CRC4(0.42)2(0.05)4(0.10)7.73 (1.49-56.38)0.0193.91 (0.91-16.87)0.0571.99 (0.39-14.35)0.428Advanced adenoma34(3.58)25(0.61)18(0.44)5.38 (3.19-9.21)<0.0017.47 (4.23-13.63)<0.0010.72 (0.38-1.31)0.281Non-advanced adenoma132(13.89)66(1.61)62(1.50)10.19 (7.51-13.97)<0.00110.71 (7.84-14.79)<0.0010.93 (0.66-1.32)0.693Advanced neoplasm38(4.00)27(0.66)22(0.53)5.58 (3.38-9.33)<0.0016.87 (4.06-11.92)<0.0010.81 (0.46-1.42)0.465Any neoplasm170(17.89)93(2.27)84(2.03)9.40 (7.20-12.34)<0.00110.47 (7.95-13.88)<0.0010.90 (0.66-1.21)0.468(c) 50-59 y#CRC3(0.37)1(0.03)6(0.19)9.83 (1.25-199.26)0.0481.81 (0.38-6.97)0.4086.35 (1.08-120.11)0.087Advanced adenoma40(4.99)28(0.88)32(1.03)5.50 (3.35-9.12)<0.0014.67 (2.89-7.60)<0.0011.21 (0.72-2.03)0.474Non-advanced adenoma119(14.86)66(2.07)83(2.67)8.34 (6.09-11.51)<0.0016.48 (4.80-8.79)<0.0011.34 (0.97-1.87)0.078Advanced neoplasm43(5.37)29(0.91)38(1.22)5.69 (3.52-9.34)<0.0014.25 (2.70-6.70)<0.0011.39 (0.85-2.29)0.188Any neoplasm162(20.22)95(2.97)121(3.89)8.35 (6.37-11.02)<0.0016.53 (5.03-8.50)<0.0011.37 (1.04-1.81)0.026(d) 60-74 y#CRC6(0.69)6(0.15)7(0.21)4.14 (1.28-13.4)0.0152.68 (0.85-8.23)0.0811.52 (0.50-4.74)0.456Advanced adenoma45(5.21)54(1.37)84(2.52)3.35 (2.21-5.05)<0.0011.59 (1.08-2.31)0.0182.08 (1.47-2.97)<0.001Non-advanced adenoma193(22.34)105(2.67)174(5.22)10.34 (8.00-13.43)<0.0014.56 (3.62-5.74)<0.0012.27 (1.77-2.93)<0.001Advanced neoplasm51(5.90)60(1.52)91(2.73)3.47 (2.34-5.11)<0.0011.68 (1.17-2.41)0.0052.03 (1.46-2.85)<0.001Any neoplasm244(28.24)165(4.19)265(7.94)8.57 (7.01-10.95)<0.0014.02 (3.27-4.95)<0.0012.28 (1.86-2.81)<0.001(e) proximal$CRC4(0.24)2(0.03)6(0.09)8.54 (1.64-62.45)0.0142.35 (0.59-8.32)0.1913.40 (0.78-23.25)0.135Advanced adenoma42(2.52)36(0.50)44(0.68)4.55 (2.89-7.21)<0.0013.00 (1.94-4.64)<0.0011.56 (1.00-2.44)0.052Non-advanced adenoma153(9.19)82(1.15)129(2.00)4.76 (3.07-7.43)<0.0014.36 (3.40-5.60)<0.0011.97 (1.49-2.62)<0.001Advanced neoplasm46(2.76)38(0.53)50(0.78)7.67 (6.06-9.76)<0.0012.94 (1.94-4.44)<0.0011.66 (1.08-2.55)0.02Any neoplasm199(11.95)120(1.68)179(2.78)4.19 (3.37-5.22)<0.0014.19 (3.37-5.22)<0.0011.89 (1.49-2.40)<0.001(f) distal$ CRC5(0.30)5(0.07)7(0.11)3.80 (1.04-13.84)0.0372.12 (0.62-6.77)0.2071.85 (0.59-6.31)0.296Advanced adenoma52(3.12)58(0.81)83(1.29)3.31 (2.24-4.86)<0.0011.92 (1.33-2.74)<0.0011.77 (1.26-2.50)<0.001Non-advanced adenoma207(12.43)110(1.54)164(2.54)9.02 (7.08-11.55)<0.0014.85 (3.90-6.05)<0.0011.84 (1.44-2.36)<0.001Advanced neoplasm57(3.42)63(0.88)90(1.40)3.36 (2.32-4.87)<0.0011.95 (1.37-2.74)<0.0011.78 (1.28-2.48)<0.001Any neoplasm264(15.86)173(2.43)254(3.94)7.44 (6.06-9.16)<0.0014.13 (3.41-5.00)<0.0011.86 (1.52-2.27)<0.001& The odds ratios and 95% confidence intervals were calculate using the logistic regression models, in which age and study center were additionally adjusted. # The odds ratios and 95% confidence intervals were calculate using the logistic regression models, in which sex and study center were additionally adjusted. $ The odds ratios and 95% confidence intervals were calculate using the logistic regression models, in which age, sex and study center were additionally adjusted. Abbreviation: 95% CI, 95% confidence interval; FIT, fecal immunochemical test. eTable 8. Quality indicators of colonoscopy performed in the colonoscopy, FIT and risk-adapted screening groupsQuality indicatorColonoscopy (N=1665)FIT(N=826)Risk-adapted screening (N=1333)Excellent or good bowel cleansing – no. (%)1429 (85.8)698 (84.4)1114 (83.6)Cecum intubation rate – no. (%)1553 (93.3)783(94.7)1246 (93.5)Withdrawal time – minutes (median, 1st -3rd quantile)15 (10-15)15 (10-15)15 (10-15)Adenoma detection rate – no. (%)406 (24.4)260 (31.5%)386 (29.0)Abbreviation: FIT, fecal immunochemical test. ................
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