NCT05482529

Brief Summary

The pathogenesis of Colorectal cancer (CRC) metastasis remains unclear.We collect clinical data from our center and use Integrative omics to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 4, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

2.4 years

First QC Date

May 4, 2022

Last Update Submit

July 29, 2022

Conditions

Keywords

Integrative omicscolorectal cancerdistant metastasisprognostic analysis

Outcome Measures

Primary Outcomes (2)

  • overall survival rate

    the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.

    3 years after surgery

  • disease free survival rate

    the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.

    3 years after surgery

Secondary Outcomes (3)

  • Quality of life outcomes evaluation(QLQ-CR38)

    0- 2 years after surgery

  • Quality of life outcomes evaluation(QLQ-C30)

    0- 2 years after surgery

  • R0 resection rate

    2 weeks after surgery

Study Arms (1)

colorectal cancer with metastasis

colorectal cancer patients with at least one distant metastasis(liver, lung)

Other: Integrative omics

Interventions

Integrative omics such as RNA-sequencing,ATAC-seq(Assay for Transposase-Accessible Chromatin using sequencing), CUT\&Tag( Cleavage Under Targets and Tagmentation)to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis.

colorectal cancer with metastasis

Eligibility Criteria

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

All patients with colorectal cancer and metastasis will be enrolled.

You may qualify if:

  • colorectal adenocarcinoma by biopsy。
  • at least 1 metastasis lesion comfirmed by at least 1 kind of imaging examination (CT, MRI and PET-CT )

You may not qualify if:

  • recent diagnosis with other malignancies
  • can not tolerate the surgery
  • history of serious mental illness
  • pregnancy or lactating women
  • the researchers believe the patients should not enrolled in

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daping hospital

Chongqing, 400042, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Colorectal cancer (CRC), adjacent colon, lymph nodes (LN) along colons, metastasis (DM), and adjacent of metastasis ,lymph nodes (LM) along metastasis ,and peripheral blood mononuclear cells (PBMC)

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 4, 2022

First Posted

August 1, 2022

Study Start

August 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations