Colorectal CancerNCT05115786
Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer
An observational study of Colorectal Cancer, run by HBI Solutions Inc..
Trial summary
A Retrospective Cohort Study to Evaluate a Multigene assay to assess the recurrence risk of colorectal cancer. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- May 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
A Retrospective Cohort Study to Evaluate a Multigene assay to assess the recurrence risk of colorectal cancer.
Read the 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
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment. | |
| Cohort B | FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment. | |
| Cohort C | FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment. | |
| Cohort D | FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of colorectal cancer
Recurrence of anatomic stage II, MMR-P and stage III A/B colorectal patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study startMay 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HBI Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- mProbe Inc.
- Responsible party
- Principal investigator, Junjie Peng, Shanghai Cancer Hospital, China
- Investigators
- Junjie Peng, M.D, Principal investigator, Shanghai Cancer Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115786
- Sponsor's protocol ID
- CRC_Relapse_001
- Status last verified
- Mar 2023
- First submitted
- 29 Oct 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study to Evaluate the Relapse Risk Test in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05115786
- Acronym / sponsor ID
- CRC_Relapse_001
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- HBI Solutions Inc.Industry (pharma, biotech, devices)
- Collaborators
- mProbe Inc.
- Study start
- May 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment. |
| Cohort B | – | –FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment. |
| Cohort C | – | –FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment. |
| Cohort D | – | –FFPE specimen collection. FFPE tumor tissue samples must be collected after surgical resection and before starting chemotherapy or other treatment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of colorectal cancer
Time frame: 5 years
Recurrence of anatomic stage II, MMR-P and stage III A/B colorectal patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junjie Peng, M.D principal investigator
Shanghai Cancer Hospital, China
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by HBI Solutions Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Schilling (6504279198, admin@mprobe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of colorectal cancer (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.