Integrative Omics Analysis for Colorectal Cancer and Metastasis

Sponsor
fan li (Other)
Overall Status
Recruiting
CT.gov ID
NCT05482529
Collaborator
(none)
20
1
41
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Integrative omics

Detailed Description

Colorectal cancer (CRC), one of the most common malignant cancer around the world, CRC patients with distant metastasis. However, the pathogenesis of metastasis remains unclear. Integrative omics have begun to enable personalized medicine at an extraordinarily detailed molecular level. All patients with colorectal cancer and metastasis in our center who meet the inclusion criteria and exclusion criteria will be enrolled. The specimen collected by surgery and clinical data will be collected . We use 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. This study will contribute to understanding the molecular mechanism of CRC metastasis in depth and contribute to the discovery of new appropriate molecular diagnostic and therapeutic targets, and more accurately prognose long term outcome in patients with CRC.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Study of Integrative Omics Analysis for Colorectal Cancer and Metastasis
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
colorectal cancer with metastasis

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

Other: Integrative omics
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.

Outcome Measures

Primary Outcome Measures

  1. overall survival rate [3 years after surgery]

    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.

  2. disease free survival rate [3 years after surgery]

    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.

Secondary Outcome Measures

  1. Quality of life outcomes evaluation(QLQ-CR38) [0- 2 years after surgery]

    We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (HRQoL).The General quality of life quality of life Questionnaires of Colorectal Cancer-38(QLQ-CR38) are used to evaluate the Quality of life outcomes. Items are scored on a four-point scale from 1("not at all) to 4 ("very much"). Raw scores are aggregated and converted to a linear scale ranging from 0 to 100, with higher scores representing a higher level of functioning or a higher level of symptoms

  2. Quality of life outcomes evaluation(QLQ-C30) [0- 2 years after surgery]

    We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (HRQoL).The General quality of life Quality of life Questionnaires of Cancer-30 (QLQ-C30) are used to evaluate the Quality of life outcomes. Items are scored on a four-point scale from 1("not at all) to 4 ("very much"). Raw scores are aggregated and converted to a linear scale ranging from 0 to 100, with higher scores representing a higher level of functioning or a higher level of symptoms

  3. R0 resection rate [2 weeks after surgery]

    The R0 resection rate by pathology outcome of specimen

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • colorectal adenocarcinoma by biopsy。

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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Daping hospital Chongqing China 400042

Sponsors and Collaborators

  • fan li

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
fan li, Prof., Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier:
NCT05482529
Other Study ID Numbers:
  • IOACCM
First Posted:
Aug 1, 2022
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by fan li, Prof., Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022