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NCT Number: NCT02809716

High Definition Single Cell Analysis in Colorectal Cancer

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.

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Key information

Conditions

Metastatic Carcinoma in the Liver Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Stage IV Colorectal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Cancer Center, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomarker Analysis

Other

Correlative studies

Cytology Specimen Collection Procedure

Other

Undergo collection of blood and tissue samples

Other names: Cytologic Sampling

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 22, 2016
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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