Microsatellite InstabilityNCT03594448
Detection of MSI in Circulating Tumor DNA of Colorectal Carcinoma Patients
An observational study of Microsatellite Instability and Colorectal Cancer Stage IV, run by University of Southern California at 2 sites in United States.
Trial summary
This pilot trial studies how well serial liquid biopsies work in detecting microsatellite instability in participants with stage IV colorectal cancer. Serial liquid biopsies may help doctors learn better methods to track cancer in the bloodstream and how to use these to improve cancer treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microsatellite Instability, Colorectal Cancer Stage IV
- What is being tested?
- Specimen Collection and Serial Liquid Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2018to 18 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy will be recruited.
Who may be able to join
- Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy.
- Trackable cancer-driver mutation in the primary tumor documented before initiation of chemotherapy.
- Zubrod performance status of 0 or 1.
- Patients have measurable disease according to RECIST version (v)1.1.
- Ability to understand and willing to sign a written informed consent.
Who cannot join
- Severe anemia (hemoglobin [Hb] < 8 g/dL).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663
About this study
Official title: Detection of Microsatellite Instability (MSI) in Circulating Tumor DNA of Patients With Stage IV Colorectal Carcinoma
This pilot trial studies how well serial liquid biopsies work in detecting microsatellite instability in participants with stage IV colorectal cancer. Serial liquid biopsies may help doctors learn better methods to track cancer in the bloodstream and how to use these to improve cancer treatments.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the hypothesis that there is high level of concordance between the electrophoretic mobility profile of microsatellite biomarkers in circulating cell-free deoxyribonucleic acid (ccfDNA) versus in primary tumor tissues in patients with colorectal carcinomas displaying microsatellite instability.
II. To test the hypothesis that changes in the electrophoretic mobility profile of microsatellite biomarkers in liquid biopsies from patients with colorectal carcinoma correlate with therapeutic responsiveness measured based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
III. To determine whether microsatellite alleles generated as a result of microsatellite instability detectable in liquid biopsy specimens from patients with colorectal carcinoma represent the entire cancer cell population or only a subset of cancer cells differentially affected by genomic instability.
OUTLINE:
Participants undergo collection of blood samples to evaluate microsatellite instability via serial liquid biopsies at baseline, then every 6 weeks and at progression or 9 months.
- Being tested
- Specimen Collection, Serial Liquid Biopsy
- Medical subject headings
- Microsatellite Instability, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen CollectionProcedure or surgery
Undergo collection of blood samples
Serial Liquid BiopsyProcedure or surgery
Undergo serial liquid biopsy
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-correlative (Specimen collection) | Participants undergo collection of blood samples in addition to the usual amount collected when they come in for their regular cancer treatments or doctor?s appointment every 6-8 weeks until disease progression or stopping at 9 months. Receives: Procedure: Specimen Collection; Procedure: Serial Liquid Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between presence of MSI present in circulating tumor DNA versus in primary tumor specimens
MSI testing distinguishes between tumors into one of 3 phenotypic categories: MSI-High (MSI-H) is reported when > 30% of biomarkers show instability; Microsatellite stable (MSS) is reported in the absence of instability. The third category, MSI-Low (MSI-L) is diagnostically equivalent to MSS, and is reported when MSI is present in < 30% of biomarkers. MSI status will be determined by polymerase chain reaction (PCR) using commercial kits provided by Promega.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start5 Sep 2018
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microsatellite InstabilityStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heinz Josef Lenz, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594448
- Sponsor's protocol ID
- 3C-18-2
- Other IDs
- NCI-2018-01169, 3C-18-2, P30CA014089
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2018
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Microsatellite Instability (MSI) in Circulating Tumor DNA of Patients With Stage IV Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT03594448
- Acronym / sponsor ID
- 3C-18-2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 20 Jul 2018 (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.
This pilot trial studies how well serial liquid biopsies work in detecting microsatellite instability in participants with stage IV colorectal cancer. Serial liquid biopsies may help doctors learn better methods to track cancer in the bloodstream and how to use these to improve cancer treatments.
Detailed description
PRIMARY OBJECTIVES:
- To test the hypothesis that there is high level of concordance between the electrophoretic mobility profile of microsatellite biomarkers in circulating cell-free deoxyribonucleic acid (ccfDNA) versus in primary tumor tissues in patients with colorectal carcinomas displaying microsatellite instability.
II. To test the hypothesis that changes in the electrophoretic mobility profile of microsatellite biomarkers in liquid biopsies from patients with colorectal carcinoma correlate with therapeutic responsiveness measured based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
III. To determine whether microsatellite alleles generated as a result of microsatellite instability detectable in liquid biopsy specimens from patients with colorectal carcinoma represent the entire cancer cell population or only a subset of cancer cells differentially affected by genomic instability.
OUTLINE:
Participants undergo collection of blood samples to evaluate microsatellite instability via serial liquid biopsies at baseline, then every 6 weeks and at progression or 9 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (Specimen collection) | – | Procedure: Specimen Collection, Procedure: Serial Liquid BiopsyParticipants undergo collection of blood samples in addition to the usual amount collected when they come in for their regular cancer treatments or doctor?s appointment every 6-8 weeks until disease progression or stopping at 9 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy will be recruited.
Key inclusion criteria (5 listed)
- Patients newly diagnosed with stage IV colorectal cancer and with defined microsatellite instability status before initiation of systemic immunotherapy.
- Trackable cancer-driver mutation in the primary tumor documented before initiation of chemotherapy.
- Zubrod performance status of 0 or 1.
- Patients have measurable disease according to RECIST version (v)1.1.
- Ability to understand and willing to sign a written informed consent.
Key exclusion criteria (1 listed)
- Severe anemia (hemoglobin [Hb] < 8 g/dL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Ancillary-correlative (Specimen collection) |
| Serial Liquid BiopsyUndergo serial liquid biopsy | Procedure or surgery | Ancillary-correlative (Specimen collection) |
Primary outcome
Correlation between presence of MSI present in circulating tumor DNA versus in primary tumor specimens
Time frame: Up to 1 year
MSI testing distinguishes between tumors into one of 3 phenotypic categories: MSI-High (MSI-H) is reported when > 30% of biomarkers show instability; Microsatellite stable (MSS) is reported in the absence of instability. The third category, MSI-Low (MSI-L) is diagnostically equivalent to MSS, and is reported when MSI is present in < 30% of biomarkers. MSI status will be determined by polymerase chain reaction (PCR) using commercial kits provided by Promega.
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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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.
Heinz Josef Lenz, MD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microsatellite Instability and Colorectal Cancer Stage IV, run by University of Southern California at 2 sites in United States.
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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between presence of MSI present in circulating tumor DNA versus in primary tumor specimens (time frame: Up to 1 year). 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 29 Aug 2024.