Stage III Colorectal Cancer AJCC v8NCT03563651
Collection of Blood, Urine, and Stool to Monitor MetastaticColorectal Cancers
An observational study of Stage III Colorectal Cancer AJCC v8 and Stage IIIA Colorectal Cancer AJCC v8, run by University of Southern California at 1 site in United States.
Trial summary
This trial studies the monitoring of therapy and progression by collecting blood, urine, and stool from participants with colorectal cancer that has spread to other places in the body or cannot be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8
- What is being tested?
- Biopsy, Biospecimen Collection and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2014to 28 May 2020
- 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: Participants with metastatic/unresectable colorectal cancer who will undergo first, second, or third line therapy at USC facilities will be recruited for this study.
Who may be able to join
- All patients with metastatic/unresectable colorectal cancer who will undergo first, second, or third line therapy; the participating investigator will select treatment, however, patients with Kras wild type must receive anti-EGFR therapy to be eligible for this study
- Subject consent to enrollment on the protocol
- Histologically confirmed metastatic or un-resectable colorectal cancer, known Kras status; knowledge of other mutations is optional
- Willingness to undergo biopsy at the time of progression
- Willingness to follow the study instructions for collection of specimens
- Available archival tissue
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Pilot Study of Monitoring Metastatic Colorectal Cancers With Liquid Biopsies
This trial studies the monitoring of therapy and progression by collecting blood, urine, and stool from participants with colorectal cancer that has spread to other places in the body or cannot be removed by surgery. Studying samples of blood, urine, and stool from participants with colorectal cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Detection of mutated Kras in urine specimen of patients with Kras mutated metastatic colon cancer on first, second, or third line therapy.
II. Detection of new Kras in urine in patients without Kras mutated metastatic colon cancer on therapy which includes anti-EGFR antibodies (cetuximab or panitumumab).
SECONDARY OBJECTIVES:
- Changes of the stool microbiome with chemotherapy and at progression of the disease.
DESCRIPTIVE OBJECTIVES:
- Changes in the quantity of mutated Kras, Braf or PI3K in urine deoxyribonucleic acid (DNA) over the cycles of first line therapy.
II. Associations between the quantity of mutated Kras, Braf or PI3K in urine DNA, molecular make up of circulating tumor cells (CTCs), cell free DNA and progression over the course of first line therapy.
III. Feasibility of detection of exosome in the plasma of colorectal cancer patients on first line chemotherapy in Dr. Fabbri?s lab at Children?s Hospital Los Angeles.
IV. Feasibility of detection of tumor DNA in the plasma of colorectal cancer patients on first line chemotherapy.
OUTLINE:
Participants undergo collection of blood and urine at baseline, on day 1 of courses 1, 2, and 3, at restaging, and at disease progression. Participants may undergo collection of stool at baseline, on day 1 of course 2, and at disease progression. Participants also undergo biopsy within 4 weeks of disease progression.
- Conditions
- Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8
- Being tested
- Biopsy, Biospecimen Collection, Laboratory Biomarker Analysis, Questionnaire Administration
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Undergo collection of blood, urine, and stool
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (biospecimen collection, biopsy) | Participants undergo collection of blood and urine at baseline, on day 1 of courses 1, 2, and 3, at restaging, and at disease progression. Participants may undergo collection of stool at baseline, on day 1 of course 2, and at disease progression. Participants also undergo biopsy within 4 weeks of disease progression. Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rates of Kras, Braf, or PI3K tumor deoxyribonucleic acid (DNA) extracted from urine in patients with pre-existing mutations
Mutation detection rate will be estimated by gene and treatment cycle in each cohort. The quantities of mutated Kras, Braf, or PI3K will be estimated using means and standard deviation if the distribution of the quantities is compatible with normal distribution. Otherwise, medians, ranges and interquartiles will be used. The changes in the mutation status and quantities of Kras, Braf, and PI3K before and after starting the first line therapy will be estimated using contingency tables and plots.
Measured: Up to 5 years
Detection rates of Kras, Braf, or PI3K tumor DNA extracted from urine in patients without pre-existing mutations
Mutation detection rate will be estimated by gene and treatment cycle in each cohort. The quantities of mutated Kras, Braf, or PI3K will be estimated using means and standard deviation if the distribution of the quantities is compatible with normal distribution. Otherwise, medians, ranges and interquartiles will be used. The changes in the mutation status and quantities of Kras, Braf, and PI3K before and after starting the first line therapy will be estimated using contingency tables and plots.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start6 Feb 2014
- Primary completion28 May 2020
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Colorectal Cancer AJCC v8Studies 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
- 29 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
- Afsaneh Barzi, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563651
- Sponsor's protocol ID
- 3C-13-2
- Other IDs
- NCI-2018-00801, 3C-13-2, P30CA014089
- Status last verified
- Nov 2021
- First submitted
- 9 Jun 2018
- Last updated
- 18 Nov 2021
- 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 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Monitoring Metastatic Colorectal Cancers With Liquid Biopsies
- ClinicalTrials.gov ID
- NCT03563651
- Acronym / sponsor ID
- 3C-13-2
- Conditions
- Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 20 Jun 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 trial studies the monitoring of therapy and progression by collecting blood, urine, and stool from participants with colorectal cancer that has spread to other places in the body or cannot be removed by surgery. Studying samples of blood, urine, and stool from participants with colorectal cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Detailed description
PRIMARY OBJECTIVES:
- Detection of mutated Kras in urine specimen of patients with Kras mutated metastatic colon cancer on first, second, or third line therapy.
II. Detection of new Kras in urine in patients without Kras mutated metastatic colon cancer on therapy which includes anti-EGFR antibodies (cetuximab or panitumumab).
SECONDARY OBJECTIVES:
- Changes of the stool microbiome with chemotherapy and at progression of the disease.
DESCRIPTIVE OBJECTIVES:
- Changes in the quantity of mutated Kras, Braf or PI3K in urine deoxyribonucleic acid (DNA) over the cycles of first line therapy.
II. Associations between the quantity of mutated Kras, Braf or PI3K in urine DNA, molecular make up of circulating tumor cells (CTCs), cell free DNA and progression over the course of first line therapy.
III. Feasibility of detection of exosome in the plasma of colorectal cancer patients on first line chemotherapy in Dr. Fabbri?s lab at Children?s Hospital Los Angeles.
IV. Feasibility of detection of tumor DNA in the plasma of colorectal cancer patients on first line chemotherapy.
OUTLINE:
Participants undergo collection of blood and urine at baseline, on day 1 of courses 1, 2, and 3, at restaging, and at disease progression. Participants may undergo collection of stool at baseline, on day 1 of course 2, and at disease progression. Participants also undergo biopsy within 4 weeks of disease progression.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (biospecimen collection, biopsy) | – | Procedure: Biopsy, Procedure: Biospecimen Collection, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants undergo collection of blood and urine at baseline, on day 1 of courses 1, 2, and 3, at restaging, and at disease progression. Participants may undergo collection of stool at baseline, on day 1 of course 2, and at disease progression. Participants also undergo biopsy within 4 weeks of disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with metastatic/unresectable colorectal cancer who will undergo first, second, or third line therapy at USC facilities will be recruited for this study.
Key inclusion criteria (6 listed)
- All patients with metastatic/unresectable colorectal cancer who will undergo first, second, or third line therapy; the participating investigator will select treatment, however, patients with Kras wild type must receive anti-EGFR therapy to be eligible for this study
- Subject consent to enrollment on the protocol
- Histologically confirmed metastatic or un-resectable colorectal cancer, known Kras status; knowledge of other mutations is optional
- Willingness to undergo biopsy at the time of progression
- Willingness to follow the study instructions for collection of specimens
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BiopsyAlso: BxUndergo biopsy | Procedure or surgery | Ancillary-Correlative (biospecimen collection, biopsy) |
| Biospecimen CollectionUndergo collection of blood, urine, and stool | Procedure or surgery | Ancillary-Correlative (biospecimen collection, biopsy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (biospecimen collection, biopsy) |
| Questionnaire AdministrationAncillary studies | Other | Ancillary-Correlative (biospecimen collection, biopsy) |
Primary outcome
Detection rates of Kras, Braf, or PI3K tumor deoxyribonucleic acid (DNA) extracted from urine in patients with pre-existing mutations
Time frame: Up to 5 years
Mutation detection rate will be estimated by gene and treatment cycle in each cohort. The quantities of mutated Kras, Braf, or PI3K will be estimated using means and standard deviation if the distribution of the quantities is compatible with normal distribution. Otherwise, medians, ranges and interquartiles will be used. The changes in the mutation status and quantities of Kras, Braf, and PI3K before and after starting the first line therapy will be estimated using contingency tables and plots.
Detection rates of Kras, Braf, or PI3K tumor DNA extracted from urine in patients without pre-existing mutations
Time frame: Up to 5 years
Mutation detection rate will be estimated by gene and treatment cycle in each cohort. The quantities of mutated Kras, Braf, or PI3K will be estimated using means and standard deviation if the distribution of the quantities is compatible with normal distribution. Otherwise, medians, ranges and interquartiles will be used. The changes in the mutation status and quantities of Kras, Braf, and PI3K before and after starting the first line therapy will be estimated using contingency tables and plots.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
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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.
Afsaneh Barzi, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage III Colorectal Cancer AJCC v8 and Stage IIIA Colorectal Cancer AJCC v8, run by University of Southern California at 1 site 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 6 inclusion and 0 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: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection rates of Kras, Braf, or PI3K tumor deoxyribonucleic acid (DNA) extracted from urine in patients with pre-existing mutations (time frame: Up to 5 years). The study lists 2 primary outcomes in all. 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 18 Nov 2021.