Integrative Omics Analysis for Colorectal Cancer and Metastasis

Colorectal Cancer Clinical Trial

Official title:

A Prospective Study of Integrative Omics Analysis for Colorectal Cancer and Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05482529
• Other study ID #: IOACCM
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: fan li, MD
• Phone: 86 023 68757958
• Email: levinecq[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
China	Daping hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
fan li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Quality of life outcomes evaluation(QLQ-CR38)	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	0- 2 years after surgery
Secondary	Quality of life outcomes evaluation(QLQ-C30)	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	0- 2 years after surgery
Secondary	R0 resection rate	The R0 resection rate by pathology outcome of specimen	2 weeks after surgery