NCT06136026

Brief Summary

This is a nationwide cohort study on integrated traditional Chinese and Western medicine for colorectal cancer. The aim is to elucidate the distribution patterns of TCM syndromes in colorectal cancer and colorectal adenoma, reveal the relationship between TCM syndromes and diagnosis, prognosis, and prognosis. Based on biological samples, a phenotypic omics study of TCM syndromes in colorectal cancer and colorectal adenoma is conducted.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
93mo left

Started Dec 2023

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Dec 2023Dec 2033

First Submitted

Initial submission to the registry

November 6, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

5.1 years

First QC Date

November 6, 2023

Last Update Submit

November 15, 2023

Conditions

Colorectal CancerColorectal Adenoma

Outcome Measures

Primary Outcomes (2)

  • Overall survival of patients with CRC

    Patients were recorded from the time they entered the study until their final death.

    5 years

  • The detection rate of Colorectal Adenomatous Polyp.

    In the follow-up plan, record the proportion of patients diagnosed with colorectal adenoma after colonoscopy examination.

    5 years

Secondary Outcomes (6)

  • Quality of life of CRC patients

    5 years

  • Recurrence rate of CRC patients

    5 years

  • Metastasis rate of CRC patients

    5 years

  • Disease-free survival (DFS) of CRC patients

    5 years

  • Progression-free survival (PFS) of CRC patients

    5 years

  • +1 more secondary outcomes

Study Arms (3)

Rectal cancer cohort

20,000 patients with rectal cancer will be included in this cohort and followed for five years.

Colon cancer cohort

20,000 patients with colon cancer will be included in this cohort and followed for five years.

Colorectal adenoma cohort

10,000 patients with colorectal adenomas will be enrolled in this cohort and followed for five years.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnostic criteria for CRC: refer to the diagnostic criteria in the 2023 Chinese Guidelines for Integrated Diagnosis and Treatment of Malignant Tumors - Colon Cancer Part. Diagnostic criteria for colorectal adenoma: Refer to the Western diagnostic criteria for colorectal adenoma in the Pathological Diagnosis Consensus of Gastrointestinal adenoma and Benign epithelial polyps published by the Digestive Diseases Group of the Pathology Society of the Chinese Medical Association.

You may qualify if:

  • CRC patients:
  • The patient is over 18 years old;
  • The patient meets the diagnostic criteria for colorectal cancer;
  • The patient has not received anti-tumor treatment such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunity in the past;
  • The patient voluntarily participated in this study and signed an informed consent form.
  • Colorectal adenoma patients
  • The patient is over 18 years old;
  • The patient meets the diagnostic criteria for colorectal adenoma;
  • The patient voluntarily participated in this study and signed an informed consent form.

You may not qualify if:

  • CRC patients:
  • Combined with other malignant tumors;
  • The patient has severe cognitive impairment, dementia, and various mental disorders.
  • Colorectal adenoma patients:
  • The patient had a history of malignancy;
  • The patient has severe cognitive impairment, dementia, and various mental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hui YF, Song SC, Zhu WJ, Bu S, Sun J, Ling TS, Cheng HB. Multicenter prospective cohort study on colorectal adenoma recurrence and malignant transformation risk based on integrative medicine: a study protocol. Front Oncol. 2025 Oct 27;15:1657390. doi: 10.3389/fonc.2025.1657390. eCollection 2025.

    PMID: 41220937DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, tongue coating, saliva, stool samples and tumor tissue were collected.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Hai bo Cheng, Professor

    Affiliated Hospital of Nanjing University of Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Hai bo Cheng, Professor

CONTACT

025-85811001hbcheng@njucm.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 18, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2033

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share