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RecruitingNCT05485077Updated Apr 17, 2024

A Prospective Cohort Study on Colorectal Cancer Screening in Community Population

An observational study in Colorectal Cancer, sponsored by Singlera Genomics Inc.. Recruiting at 1 site in China. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Singlera Genomics Inc. · Observational

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
18,000
Ages
40 Years and older
Sex
All
01

Study summary

This study will validate the real world results of polygene methylation detection in colorectal cancer in a large prospective community cohort. In this study, questionnaire survey and polygene methylation detection technology of colorectal cancer were used as preliminary screening methods, and colonoscopy was used as further validation examination method to screen colorectal cancer and precancerous lesions. The diagnosis and outcome of all lesions were based on colonoscopy and pathological examination.

Read the detailed description
  1. The informed consent signed by shougang Community will be completed in the baseline period: Colorectal cancer risk factors assessment questionnaire, medical history collection, fecal immunochemical (FIT), carcinoembryonic antigen (CEA) blood test and blood bowel cancer gene methylation detection, for colorectal cancer gene methylation detection results more positive subjects and the result of the negative part of the subjects (n = 500), within 3 months after receiving the results complete colonoscopy.
  2. Follow-up at 1, 2, 3, 4, and 5 years after baseline included: ① Central follow-up at 1, 3, and 5 years: history collection, colonoscopy, FIT test, and CEA examination; ② Telephone follow-up at the 2nd and 4th years: medical history was collected; (3) Survival outcome registration was performed in the fifth year; Follow-up history was collected at 1, 2, 3, 4, and 5 years after completion of baseline, and survival outcomes were registered at 5 years.
  3. During the follow-up, the subjects were confirmed to be diagnosed with colorectal cancer by evaluation (colorectal cancer was diagnosed by colonoscopy), and the subjects who were treated after polyps or adenomas were found during colonoscopy also reached the study endpoint.
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Conditions studied

  • Colorectal Cancer

Keywords

  • ctDNA methylation
  • Community population screening
03

In context

Colorectal Neoplasms

5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 18,000 is above the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Singlera Genomics Inc. is the lead sponsor of 14 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

18000 samples from Shougang community

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Chronological age ≥40 years;
  2. Full capacity for action;
  3. After enrollment, the participants were able to complete the Colorectal Cancer Risk Factor Assessment Questionnaire and the annual follow-up interviews;
  4. In the course of the study, the information related to tumor diagnosis in other hospitals can be timely fed back to the researchers;

Exclusion criteria

Exclusion Criteria:

  1. History of colorectal cancer and other malignant tumors;
  2. Previous colorectal resection;
  3. undergoing any cancer-related treatment;
  4. Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months;
  5. Participate in other interventional clinical investigators within 3 months;
  6. Pregnant or lactating women;
  7. Have autoimmune disease, hereditary disease, mental illness/disability, etc
  8. Poor compliance, unable to complete the study.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
18,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Positive group

    All the subjects who completed colorectal cancer polygene methylation test at baseline completed colonoscopy within 3 months. Colorectal cancer diagnosed by colonoscopy, adenoma or polyp lesions found after treatment will reach the end of the study. The tumor history of family members was tracked for patients who met the end point of the study. The positive subjects who did not reach the end point of the study underwent three center visits at 12, 36 and 60 months after enrollment respectively, including history taking, colonoscopy, FIT test and blood CEA test. Another telephone follow-up was conducted at 24 and 48 months, respectively.

  • Negative group

    The subjects who completed colorectal cancer polygene methylation test at baseline, and those with negative test results (n= 500, direct extraction method) completed colonoscopy within 3 months. The end points and follow-up were the same as those in the positive group. The negative group was compared with the positive group to observe the difference of negative predictive value and survival outcome.

06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of polygene methylation detection in colorectal cancer

    To investigate the sensitivity and specificity of polygene methylation in the diagnosis of colorectal cancer in community population, and to evaluate its value as an auxiliary diagnosis

    Time frame: assessed up to 72 months

  2. Negative predictive value and positive predictive value of polygene methylation in colorectal cancer

    To obtain the positive predictive value and negative predictive value of polygene methylation test for colorectal cancer early screening, and compare with FIT test and blood CEA test.

    Time frame: assessed up to 72 months

07

Study locations

1 of 1 sites recruiting
  • Peking University Shougang Hospital
    Beijing, Beijing Municipality 100144, China
    • Jin Gu, Doctor · Contact · yuanping_632@163.com · 010-57830127
    • Ping Yuan · Contact · 15210919487
    Recruiting
08

References and documents

Publications

  • Schlemper RJ, Riddell RH, Kato Y, Borchard F, Cooper HS, Dawsey SM, Dixon MF, Fenoglio-Preiser CM, Flejou JF, Geboes K, Hattori T, Hirota T, Itabashi M, Iwafuchi M, Iwashita A, Kim YI, Kirchner T, Klimpfinger M, Koike M, Lauwers GY, Lewin KJ, Oberhuber G, Offner F, Price AB, Rubio CA, Shimizu M, Shimoda T, Sipponen P, Solcia E, Stolte M, Watanabe H, Yamabe H. The Vienna classification of gastrointestinal epithelial neoplasia. Gut. 2000 Aug;47(2):251-5. doi: 10.1136/gut.47.2.251. PubMed 10896917 ↗
  • Guo S, Diep D, Plongthongkum N, Fung HL, Zhang K, Zhang K. Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet. 2017 Apr;49(4):635-642. doi: 10.1038/ng.3805. Epub 2017 Mar 6. PubMed 28263317 ↗
  • Cai G, Cai M, Feng Z, Liu R, Liang L, Zhou P; ColonAiQ Group; Zhu B, Mo S, Wang H, Lan X, Cai S, Xu Y, Wang R, Dai W, Han L, Xiang W, Wang B, Guo W, Zhang L, Zhou C, Luo B, Li Y, Nie Y, Ma C, Su Z. A Multilocus Blood-Based Assay Targeting Circulating Tumor DNA Methylation Enables Early Detection and Early Relapse Prediction of Colorectal Cancer. Gastroenterology. 2021 Dec;161(6):2053-2056.e2. doi: 10.1053/j.gastro.2021.08.054. Epub 2021 Sep 4. No abstract available. PubMed 34487783 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2022 (actual). Primary completion is estimated for Jul 2028, 72 months after the start.

Of 101 industry-sponsored observational studies under Colorectal Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 64. This study's planned 72 months is above that.

Counting every sponsor, half of 562 studies reached it within 53 months; a quarter within 28 and three quarters within 103.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2022
First posted
Aug 3, 2022
StartActual
Jul 9, 2022
Primary completionEst.
Jul 9, 2028
CompletionEst.
Jul 9, 2028
Last update
Apr 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05485077
Lead sponsor
Singlera Genomics Inc.
Collaborators
Peking University Shougang Hospital
Responsible party
Sponsor
First posted
Aug 3, 2022
Start date
Jul 9, 2022
Primary completion
Jul 9, 2028 (estimated)
Completion
Jul 9, 2028 (estimated)
Last update
Apr 17, 2024

Study contacts

Jin Gu, Doctor
Contact
yuanping_632@163.com
010-57830127
Ping Yuan
Contact
15210919487
Rui Liu, Doctor
principal investigator · Singlera Genomics Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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