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High Definition Single Cell Analysis in Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02809716
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief 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 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.

Condition or disease Intervention/treatment
Metastatic Carcinoma in the Liver Stage IV Colorectal Cancer Other: Biomarker Analysis Other: Cytology Specimen Collection Procedure

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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:

I. 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.


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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: High Definition Single Cell Analysis in Colorectal Cancer
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Biomarker Analysis
Correlative studies

Other: Cytology Specimen Collection Procedure
Undergo collection of blood and tissue samples
Other Name: Cytologic Sampling




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    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.


Biospecimen Retention:   Samples With DNA
Blood, tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic CRC with single- and multi-focal hepatic lesions scheduled for resection (metastatectomy)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809716


Contacts
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Contact: Dana Agafitei 323-865-0467 Raluca.Agafitei@med.usc.edu

Locations
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United States, California
Scripps Cancer Center Not yet recruiting
La Jolla, California, United States, 92037
Contact: Peter Kuhn    323-865-3000    peter.kuhn@usc.edu   
Principal Investigator: Peter Kuhn         
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Peter Kuhn    323-865-3000    peter.kuhn@usc.edu   
Principal Investigator: Peter Kuhn         
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Peter Kuhn    323-865-3000    peter.kuhn@usc.edu   
Principal Investigator: Peter Kuhn         
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Contact: Alicia Bogardus, MA       Alicia.bogardus@hoag.org   
Principal Investigator: Diana Hanna, MD         
USC Norris Oncology/Hematology-Newport Beach Recruiting
Newport Beach, California, United States, 92663
Contact: Kristy Massopust       Kristy.Massopust@med.usc.edu   
Principal Investigator: Greg Angstreich, MD         
United States, Texas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Peter Kuhn    323-865-3000    peter.kuhn@usc.edu   
Principal Investigator: Peter Kuhn         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Peter Kuhn University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02809716     History of Changes
Other Study ID Numbers: 3C-15-4
NCI-2016-00736 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
3C-15-4 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases