Integrative Omics Analysis for Colorectal Cancer and Metastasis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: fan li, MD; Phone Number: 86 023 68757958; Email: levinecq@163.com

Study Locations

• China
  • Chongqing, China, 400042
    • Recruiting
    • Daping Hospital
    • Contact: fan Li, PhD; Phone Number: 68729350; Email: levinecq@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with colorectal cancer and metastasis will be enrolled.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
R0 resection rate	The R0 resection rate by pathology outcome of specimen	2 weeks after surgery

Collaborators and Investigators

• Sponsor: fan li

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: colorectal cancer; distant metastasis; Integrative omics; prognostic analysis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: IOACCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No