Clinical trial NCT05115786: Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer
Official title: Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Lead sponsor: HBI Solutions Inc.
Sponsor class: INDUSTRY
Collaborators: name: mProbe Inc.
First posted: 2021-11-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Recurrence of colorectal cancer
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Cancer Hospital, China
name: Junjie Peng, M.D
role: PRINCIPAL_INVESTIGATOR
References: