Back to resultsMeasuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases
Primary Purpose
Colorectal Cancer, Residual Disease
Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
blood draw
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- planned colorectal primary surgery
Exclusion Criteria:
- unfit patients with dementia
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CRC patients after primary surgery
Arm Description
sequential blood draw taken to monitor residual disease
Outcomes
Primary Outcome Measures
ctDNA level
residual disease measured by sequential blood draws
Secondary Outcome Measures
Full Information
NCT ID
NCT03189576
First Posted
June 14, 2017
Last Updated
May 25, 2023
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03189576
Brief Title
Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases
Official Title
Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Circulating tumour DNA (ctDNA) is a promising tool when monitoring the residual disease in colorectal cancer (CRC). Current staging procedures are insufficient to identify the patient cohort at high risk, who might benefit from additional adjuvant therapy.
We will show that the assessment of ctDNA is a non-invasive approach and easily taken at different time points via simple blood draw to monitor residual disease from the colorectal cancer patients after primary surgery. Minimal residual disease could be used in the future for individualized treatment decisions after primary surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Residual Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CRC patients after primary surgery
Arm Type
Other
Arm Description
sequential blood draw taken to monitor residual disease
Intervention Type
Diagnostic Test
Intervention Name(s)
blood draw
Primary Outcome Measure Information:
Title
ctDNA level
Description
residual disease measured by sequential blood draws
Time Frame
3-6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
planned colorectal primary surgery
Exclusion Criteria:
unfit patients with dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pirkko-Liisa Kellokumpu-Lehtinen, professor
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases
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