Molecular Stethoscope

Colonic Neoplasms Clinical Trial

Official title:

Molecular Stethoscope for Colon Cancer Detection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578264
• Other study ID #: 15-6616
• Status: Completed
• Start date: June 2015
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2020
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	Sequenom, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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