Molecular Stethoscope

NCT02578264 | Completed

• 1 other identifier: 15-6616
• Study Type: observational
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All participants

All subjects enrolled in the study will provide tumor and normal tissue and blood samples.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scripps Translational Science Institute: lead
• Sequenom, Inc.: collaborator

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Eric Topol, MD

  Scripps Translational Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Scripps Translational Science Institute

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 16, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03