Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer

NCT05115786 | Unknown

• 1 other identifier: CRC_Relapse_001
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Retrospective Cohort Study to Evaluate a Multigene assay to assess the recurrence risk of colorectal cancer.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence of colorectal cancer

  Recurrence of anatomic stage II, MMR-P and stage III A/B colorectal patients

  5 years

Study Arms (4)

Cohort A

FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.

Cohort B

FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.

Cohort C

FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.

Cohort D

FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. As such, all eligible patients must have a stored tumor specimen which can be accessed for analysis.

You may qualify if:

• Subjects must be 20 years of age or older.
• Subjects was diagnosed with anatomic stage II, T3, MMR-P colorectal cancer
• Subjects had recurrence date information within 5 years follow-up after initial tumor resection surgery
• Subject is able and willing to provide FFPE sample per protocol
• Subject is able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study

You may not qualify if:

• No tumor block available from initial diagnosis before any chemotherapy treatment
• Presence of synchronous tumors
• No tumor or very little tumor (\<5% tumor present) in block as assessed designated pathologist.
• Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H\&E slide by designated pathologist.
• Insufficient RNA (\<5 ng/μL or 300 ng) for RT-PCR analysis.
• Failure of assay to meet pre-specified quality control (QC) specifications.
• Cohort B
• Subjects must be 20 years of age or older.
• Subjects was diagnosed with anatomic stage II, T3, MMR-P colorectal cancer
• Subjects had 5 years follow-up information after initial tumor resection surgery
• Subject is able and willing to provide FFPE sample per protocol
• Subject is able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
• No tumor block available from initial diagnosis before any chemotherapy treatment
• Presence of synchronous tumors
• No tumor or very little tumor (\<5% tumor present) in block as assessed designated pathologist.

Sponsors & Collaborators

• HBI Solutions Inc.: lead
• mProbe Inc.: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

FFPE

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Junjie Peng, M.D

  Shanghai Cancer Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Schilling

CONTACT

6504279198; admin@mprobe.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: May 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03