Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer

Detailed Description

Colon cancer is the fourth most prevalent cancer for both men and women and also the third most common cause of cancer-related deaths worldwide. The primary consideration in deciding whether the moderate benefits from adjuvant chemotherapy for colon cancer (a 20% to 25%proportional reduction in the risk of recurrence and death) will be worth-while is the likelihood of disease recurrence, with larger absolute benefits for higher-risk patients. Nevertheless, the recurrence of cancer and decisions about its treatment still rely largely on classic histopathological and immuno histochemical techniques.

The purpose of this study is to validate a previously developed multigene assay for a more quantitative approach to predict the recurrence risk and rational individualization of treatment are needed. A retrospective cohort of stage II and stage III patients with average 5 years follow up after resection surgery will be selected. Formalin fixed paraffin-embedded (FFPE) tumor tissue collected during patients' resection surgery with either recurrence or non-recurrence follow-up will be used validate the test. This multigene assay result will provide a precise estimate of the risk of recurrence and chemotherapy benefit for colorectal patients to help guide the most appropriate treatment decision.

Three types of patients in this study:

Cohort A

People ages 20 year or older who were diagnosed with anatomic stage II, T3, MMR-P colorectal cancer and had recurrence of tumor within 5 years follow-up. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.

Cohort B

People ages 20 year or older who were diagnosed with anatomic stage II, T3, MMR-P colorectal cancer and had no-recurrence of tumor within 5 years follow-up. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.

Cohort C

People ages 20 year or older who were diagnosed with stage III A/B colorectal cancer and had recurrence of tumor within 5 years follow-up. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.

Cohort D

People ages 20 year or older who were diagnosed with stage III A/B colorectal cancer and had no-recurrence of tumor within 5 years follow-up. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Cohort A

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 C

Inclusion Criteria:

• Subjects must be 20 years of age or older.
• Subjects was diagnosed with anatomic stage III A/B 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

Exclusion Criteria:

• 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 D

Inclusion Criteria:

• Subjects must be 20 years of age or older.
• Subjects was diagnosed with anatomic stage III A/B 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of colorectal cancer	Recurrence of anatomic stage II, MMR-P and stage III A/B colorectal patients	5 years

Collaborators and Investigators

• Sponsor: HBI Solutions Inc.
• Collaborators: mProbe Inc.
• Investigators: Principal Investigator: Junjie Peng, M.D, Shanghai Cancer Hospital, China

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CRC_Relapse_001

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