Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer

HBI Solutions

Status

Not yet enrolling

Conditions

Colorectal Cancer

Study type

Observational

Funder types

Industry

Identifiers

NCT05115786

CRC_Relapse_001

Details and patient eligibility

About

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

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.