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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02578264
Other study ID # 15-6616
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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