Molecular Stethoscope

Molecular Stethoscope for Colon Cancer Detection

The study aims to provide a more complete characterization and understanding of the genetic causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of this study will be used to develop early detection tests for colorectal cancer that are minimally invasive (based on a blood test). It is hoped that reliable, minimally invasive, early detection methods will lead to improved screening rates, increased screening safety, longer colorectal cancer survival, and overall cost savings.

In order to assess the test's ability to detect tumor DNA, 25 participants with known colorectal cancer who will be undergoing surgical resection of the colon as part of their clinical care will be recruited. The investigators will collect blood from participants prior to surgery, tumor and normal tissue removed during surgery, a series of blood samples after surgery for up to one year and relevant medical records. DNA variants identified in blood will be compared against tissue samples. Serial samples will be analyzed to assess the variance in amount of circulating tumor DNA across time with standard treatment.

Study Overview

• Status: Completed
• Conditions: Colonic Neoplasms

• Study Type: Observational
• Enrollment (Actual): 26

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal cancer that will be receiving surgical removal of their cancer as part of their care.

Description

Inclusion Criteria:

• Colorectal cancer sent for surgical colonic resection (all stages) OR
• High risk adenoma sent for surgical colonic resection

Exclusion Criteria:

• Chemotherapy before surgical treatment
• Invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection
• Radiation therapy before surgical treatment
• Bone marrow transplant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All participants; All subjects enrolled in the study will provide tumor and normal tissue and blood samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining sensitivity of assay in known cancer patients	The sensitivity (% positive out of all diseased patients) of circulating tumor DNA detection from the blood samples will be calculated against the gold standard of surgical pathology reports in this pilot group of patients with known colorectal cancer.	2 years

Collaborators and Investigators

• Sponsor: Scripps Translational Science Institute
• Collaborators: Sequenom, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 15-6616