Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05115786
• Other study ID #: CRC_Relapse_001
• Status: Not yet recruiting
• Start date: May 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: HBI Solutions Inc.
• Contact: James Schilling
• Phone: 6504279198
• Email: admin[@]mprobe.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
HBI Solutions Inc.	mProbe Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of colorectal cancer	Recurrence of anatomic stage II, MMR-P and stage III A/B colorectal patients	5 years