Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer

Not yet recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT05115786
• Lead Sponsor: HBI Solutions Inc.

Brief Summary

A Retrospective Cohort Study to Evaluate a Multigene assay to assess the recurrence risk of 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 Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23
• Study Start: 2023-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of colorectal cancer	5 years	Recurrence of anatomic stage II, MMR-P and stage III A/B colorectal patients