Metastatic Carcinoma in the LiverNCT02809716
High Definition Single Cell Analysis in Colorectal Cancer
An observational study of Metastatic Carcinoma in the Liver and Stage IV Colorectal Cancer, run by University of Southern California at 6 sites in United States.
Trial summary
This research clinical trial studies high definition single cell analysis in blood and tissue samples from patients with colorectal cancer which has spread to the liver. High definition single cell analysis allows doctors to study the properties of cancer cells that are sometimes found in the blood of patients and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Carcinoma in the Liver, Stage IV Colorectal Cancer
- What is being tested?
- Biomarker Analysis and Cytology Specimen Collection Procedure
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Aug 2016to 29 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: Patients with metastatic CRC with single- and multi-focal hepatic lesions scheduled for resection (metastatectomy)
Who may be able to join
- Able to provide informed consent
- Metastatic colorectal adenocarcinoma to the liver (hepatic mCRC)
- Synchronous or metachronous
- Solitary or multifocal
- Concurrent abdominal lymph node metastasis is allowable
- Hepatic mCRC deemed surgically resectable by the study team with plans to undergo surgery
- Has not received any systemic chemotherapy for at least 21 days prior to scheduled hepatic resection
Who cannot join
- Non-adenocarcinoma metastatic colorectal cancer (e.g. neuroendocrine carcinoma); mucinous component is permitted
- Metastatic CRC that involves organ(s)/tissue(s) other than abdominal lymph nodes and/or liver
- Has received any systemic chemotherapy within 21 days prior to scheduled hepatic resection
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Scripps Cancer Center
La Jolla, California, 92037
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663
About this study
This research clinical trial studies high definition single cell analysis in blood and tissue samples from patients with colorectal cancer which has spread to the liver. High definition single cell analysis allows doctors to study the properties of cancer cells that are sometimes found in the blood of patients and to determine how the genes and proteins in them may change over time. Studying samples from patients with colorectal cancer in the laboratory may help doctors learn more about how cancer spreads, as well as how to predict the disease outcomes in patients with cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the level of correlation between solid tumor touch preparations and liquid biopsies (circulating tumor cells [CTCs]) from patients with surgically resected colorectal cancer (CRC) metastases to the liver using single-cell high-content analysis, including gene copy number variation (CNV) and to establish one or more bio-signatures that represent the liquid and solid biopsy correlation for each patient and for the patient population.
SECONDARY OBJECTIVES:
- To demonstrate the technical validity and reproducibility of the bio-signatures by comparing the two pre-resection liquid biopsy samples drawn one week prior to and on the day of surgery.
TERTIARY OBJECTIVES:
- Compare biosignatures between pre-surgical and post-surgical blood samples. II. Compare biosignatures between resected metastatic liver tumor tissue, primary colon tumor tissue (if available), and pre-surgical blood samples.
III. Compare biosignatures between blood samples prior to resection with those obtained after resection and at the time of recurrence.
OUTLINE:
Patients undergo blood collection 1 week prior surgery, before and after surgery on the same day, and 1 week and 3 months after surgery. Patients also undergo tissue collection during the surgery. Blood and tissue samples are processed for high definition single cell analysis including whole-genome CNV profiles, protein expression, and cell morphology.
After completion of study, patients are followed up for up to 2 years.
- Being tested
- Biomarker Analysis, Cytology Specimen Collection Procedure
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker AnalysisOther
Correlative studies
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo collection of blood and tissue samples
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (blood and tumor tissue collection) | Patients undergo collection of blood collection 1 week prior surgery, before and after surgery on the same day, and 1 week and 3 months after surgery. Patients also undergo and tissue collection during the surgery. Blood and tissue samples are processed for high definition single cell analysis including, whole-genome CNV profiles, protein expression, and cell morphology. Receives: Other: Biomarker Analysis; Other: Cytology Specimen Collection Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
HD-SCA liquid biopsy biosignatures assessed by cell morphology, protein expression, and whole genome CNV profiles
Biosignatures will be compared between cells from tumor tissue within the same patient, cells from blood samples within the same patient, cells from tumor tissue and blood samples within the same patient, cells from tumor tissue and blood samples across different patients. Upon these comparisons, biosignatures will be established which represent liquid and solid biopsy correlations for each patient and for the patient population. Descriptive statistics will be used to determine means, correlations, and variability of biosignatures between different specimens and time points, and within and acr
Measured: Up to 2 years
HD-SCA solid tumor biosignatures assessed by cell morphology, protein expression, and whole genome CNV profiles
Biosignatures will be compared between cells from tumor tissue within the same patient, cells from blood samples within the same patient, cells from tumor tissue and blood samples within the same patient, cells from tumor tissue and blood samples across different patients. Upon these comparisons, biosignatures will be established which represent liquid and solid biopsy correlations for each patient and for the patient population. Descriptive statistics will be used to determine means, correlations, and variability of biosignatures between different specimens and time points, and within and acr
Measured: Up to 2 years
Secondary outcomes (1)
HD-SCA biosignatures in pre-resection liquid biopsy samples assessed by cell morphology, protein expression, and whole genome CNV profiles
The technical validity and reproducibility of the biosignatures will be demonstrated by comparing two pre-resection liquid biopsy samples. This reflects a change in the timing of specimen collection from the original protocol. Descriptive statistics will be used to determine means, correlations, and variability of biosignatures between different specimens and time points, and within and across patients.
Measured: Up to day 1 of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start1 Aug 2016
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Carcinoma in the LiverStudies 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
- 24 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
- Peter Kuhn, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809716
- Sponsor's protocol ID
- 3C-15-4
- Other IDs
- NCI-2016-00736, 3C-15-4, P30CA014089
- Status last verified
- Aug 2023
- First submitted
- 19 Jun 2016
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Single Cell Analysis in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02809716
- Acronym / sponsor ID
- 3C-15-4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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 research clinical trial studies high definition single cell analysis in blood and tissue samples from patients with colorectal cancer which has spread to the liver. High definition single cell analysis allows doctors to study the properties of cancer cells that are sometimes found in the blood of patients and to determine how the genes and proteins in them may change over time. Studying samples from patients with colorectal cancer in the laboratory may help doctors learn more about how cancer spreads, as well as how to predict the disease outcomes in patients with cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the level of correlation between solid tumor touch preparations and liquid biopsies (circulating tumor cells [CTCs]) from patients with surgically resected colorectal cancer (CRC) metastases to the liver using single-cell high-content analysis, including gene copy number variation (CNV) and to establish one or more bio-signatures that represent the liquid and solid biopsy correlation for each patient and for the patient population.
SECONDARY OBJECTIVES:
- To demonstrate the technical validity and reproducibility of the bio-signatures by comparing the two pre-resection liquid biopsy samples drawn one week prior to and on the day of surgery.
TERTIARY OBJECTIVES:
- Compare biosignatures between pre-surgical and post-surgical blood samples. II. Compare biosignatures between resected metastatic liver tumor tissue, primary colon tumor tissue (if available), and pre-surgical blood samples.
III. Compare biosignatures between blood samples prior to resection with those obtained after resection and at the time of recurrence.
OUTLINE:
Patients undergo blood collection 1 week prior surgery, before and after surgery on the same day, and 1 week and 3 months after surgery. Patients also undergo tissue collection during the surgery. Blood and tissue samples are processed for high definition single cell analysis including whole-genome CNV profiles, protein expression, and cell morphology.
After completion of study, patients are followed up for up to 2 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (blood and tumor tissue collection) | – | Other: Biomarker Analysis, Other: Cytology Specimen Collection ProcedurePatients undergo collection of blood collection 1 week prior surgery, before and after surgery on the same day, and 1 week and 3 months after surgery. Patients also undergo and tissue collection during the surgery. Blood and tissue samples are processed for high definition single cell analysis including, whole-genome CNV profiles, protein expression, and cell morphology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic CRC with single- and multi-focal hepatic lesions scheduled for resection (metastatectomy)
Key inclusion criteria (7 listed)
- Able to provide informed consent
- Metastatic colorectal adenocarcinoma to the liver (hepatic mCRC)
- Hepatic mCRC deemed surgically resectable by the study team with plans to undergo surgery
- Has not received any systemic chemotherapy for at least 21 days prior to scheduled hepatic resection
Key exclusion criteria (3 listed)
- Non-adenocarcinoma metastatic colorectal cancer (e.g. neuroendocrine carcinoma); mucinous component is permitted
- Metastatic CRC that involves organ(s)/tissue(s) other than abdominal lymph nodes and/or liver
- Has received any systemic chemotherapy within 21 days prior to scheduled hepatic resection
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 |
|---|---|---|
| Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (blood and tumor tissue collection) |
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo collection of blood and tissue samples | Other | Ancillary-Correlative (blood and tumor tissue collection) |
Primary outcome
HD-SCA liquid biopsy biosignatures assessed by cell morphology, protein expression, and whole genome CNV profiles
Time frame: Up to 2 years
Biosignatures will be compared between cells from tumor tissue within the same patient, cells from blood samples within the same patient, cells from tumor tissue and blood samples within the same patient, cells from tumor tissue and blood samples across different patients. Upon these comparisons, biosignatures will be established which represent liquid and solid biopsy correlations for each patient and for the patient population. Descriptive statistics will be used to determine means, correlations, and variability of biosignatures between different specimens and time points, and within and acr
HD-SCA solid tumor biosignatures assessed by cell morphology, protein expression, and whole genome CNV profiles
Time frame: Up to 2 years
Biosignatures will be compared between cells from tumor tissue within the same patient, cells from blood samples within the same patient, cells from tumor tissue and blood samples within the same patient, cells from tumor tissue and blood samples across different patients. Upon these comparisons, biosignatures will be established which represent liquid and solid biopsy correlations for each patient and for the patient population. Descriptive statistics will be used to determine means, correlations, and variability of biosignatures between different specimens and time points, and within and acr
1 secondary outcome
HD-SCA biosignatures in pre-resection liquid biopsy samples assessed by cell morphology, protein expression, and whole genome CNV profiles
Time frame: Up to day 1 of surgery
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 14 Aug 2023.
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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.
Peter Kuhn principal investigator
University of Southern California
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Carcinoma in the Liver and Stage IV Colorectal Cancer, run by University of Southern California at 6 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 7 inclusion and 3 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
HD-SCA liquid biopsy biosignatures assessed by cell morphology, protein expression, and whole genome CNV profiles (time frame: Up to 2 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 14 Aug 2023.