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NCT Number: NCT05485077

A Prospective Cohort Study on Colorectal Cancer Screening in Community Population

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100144, China

Location status: Recruiting

Location contact

Jin Gu, Doctor

CONTACT

[email protected]

010-57830127

Ping Yuan

CONTACT

15210919487

About this study

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronological age ≥40 years;
  • Full capacity for action;
  • After enrollment, the participants were able to complete the Colorectal Cancer Risk Factor Assessment Questionnaire and the annual follow-up interviews;
  • 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

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

Treatment and study plan

Primary outcomes

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

    Time frame: assessed up to 72 months

    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

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

    Time frame: assessed up to 72 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Gu, Doctor

CONTACT

[email protected]

010-57830127

Ping Yuan

CONTACT

15210919487

Sponsors and collaborators

Lead sponsor

Singlera Genomics Inc.

Industry

Collaborators

  • Peking University Shougang Hospital

Registry information

Official study title

Colorectal Cancer Screening Cohort Study in Shougang Community Population Based on Polygene Methylation Detection Technology

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2022
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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