High Definition Single Cell Analysis in Colorectal Cancer

Stage IV Colorectal Cancer Clinical Trial

Official title:

High Definition Single Cell Analysis in Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809716
• Other study ID #: 3C-15-4
• Secondary ID: NCI-2016-007363C
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: May 29, 2020

Study information

• Verified date: August 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 29, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Carcinoma in the Liver
• Stage IV Colorectal Cancer

Intervention

Other:
• Biomarker Analysis
Correlative studies
• Cytology Specimen Collection Procedure
Undergo collection of blood and tissue samples

Locations

Country	Name	City	State
United States	Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas
United States	Scripps Cancer Center	La Jolla	California
United States	Los Angeles County-USC Medical Center	Los Angeles	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	USC Norris Oncology/Hematology-Newport Beach	Newport Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 2 years
Primary	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	Up to 2 years
Secondary	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.	Up to day 1 of surgery