Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer

NCT ID: NCT05115786

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-12-31

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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort A

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

No interventions assigned to this group

Cohort B

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

No interventions assigned to this group

Cohort C

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

No interventions assigned to this group

Cohort D

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

No interventions assigned to this group

Eligibility Criteria

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

• 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

• 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

• 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.

Cohort B

• 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

• 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

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

mProbe Inc.

INDUSTRY

Sponsor Role: collaborator

HBI Solutions Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Junjie Peng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junjie Peng, M.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Cancer Hospital, China

Central Contacts

James Schilling

Role: CONTACT

admin@mprobe.com

6504279198

Other Identifiers

CRC_Relapse_001

Identifier Type: -

Identifier Source: org_study_id