NCT06852495

Brief Summary

The aim of this study is to investigate the effects of environmental factors, such as air pollution, on the occurrence, development and prognosis of colorectal cancer; to identify metabolic markers specific to colorectal cancer patients, which will provide a basis for early diagnosis, early intervention and individualized treatment; and to comprehensively understand the mechanism of the occurrence and development of colorectal cancer by integrating the data of environmental factors and the macro-genome, and to develop new predictive and therapeutic strategies.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Progress51%
Nov 2024Nov 2027

Study Start

First participant enrolled

November 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

February 25, 2025

Last Update Submit

February 25, 2025

Conditions

Keywords

Colorectal cancerMacrogenomeEnvironmental pollutionair pollution

Outcome Measures

Primary Outcomes (1)

  • prognosis

    Overall survival (OS), from date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first.

    From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months

Secondary Outcomes (1)

  • Macrogenomic differences

    The date of macrogenomic testing, assessed up to 1 week after surgery.

Study Arms (2)

the colorectal cancer group

patients diagnosed with colorectal cancer

the control group

Healthy individuals with no history of malignant tumor

Eligibility Criteria

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

Patients diagnosed with colorectal cancer by pathological biopsy and healthy participants with no history of malignancy were included in the study.

You may qualify if:

  • Age ≥18 years old;
  • Patients diagnosed with colorectal cancer by pathologic biopsy before surgery;
  • Patients did not undergo chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment;
  • Willing to participate in the study and sign an informed consent form. Complete clinical data.

You may not qualify if:

  • Concurrent primary malignant tumor other than colorectal cancer;
  • Patients with severe cardiopulmonary insufficiency or other systemic diseases that affect the choice of treatment plan;
  • Inappropriate for enrollment as assessed by the investigator;
  • Incomplete clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2025

First Posted

February 28, 2025

Study Start

November 1, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Data sharing is not permitted by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University.

Locations