Clinical trial NCT02809716: High Definition Single Cell Analysis in Colorectal Cancer
Official title: High Definition Single Cell Analysis in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Carcinoma in the Liver
Stage IV Colorectal Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-06-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic CRC with single- and multi-focal hepatic lesions scheduled for resection (metastatectomy)

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.

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.

Eligibility 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

Primary outcomes:
measure: HD-SCA liquid biopsy biosignatures assessed by cell morphology, protein expression, and whole genome CNV profiles
timeFrame: Up to 2 years
measure: HD-SCA solid tumor biosignatures assessed by cell morphology, protein expression, and whole genome CNV profiles
timeFrame: Up to 2 years
Secondary outcomes:
measure: HD-SCA biosignatures in pre-resection liquid biopsy samples assessed by cell morphology, protein expression, and whole genome CNV profiles
timeFrame: Up to day 1 of surgery
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Cancer Center
state: California
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Newport Beach
country: United States
facility: USC Norris Oncology/Hematology-Newport Beach
state: California
city: Houston
country: United States
facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
state: Texas
Study officials:
affiliation: University of Southern California
name: Peter Kuhn
role: PRINCIPAL_INVESTIGATOR
References: