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Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03189576
Recruitment Status : Active, not recruiting
First Posted : June 16, 2017
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital

Tracking Information
First Submitted Date  ICMJE June 14, 2017
First Posted Date  ICMJE June 16, 2017
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE October 1, 2015
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2017)
ctDNA level [ Time Frame: 3-6 months ]
residual disease measured by sequential blood draws
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases
Official Title  ICMJE Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Colorectal Cancer
  • Residual Disease
Intervention  ICMJE Diagnostic Test: blood draw
Study Arms  ICMJE CRC patients after primary surgery
sequential blood draw taken to monitor residual disease
Intervention: Diagnostic Test: blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2017)
37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • planned colorectal primary surgery

Exclusion Criteria:

  • unfit patients with dementia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03189576
Other Study ID Numbers  ICMJE ETL R15085
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital
Study Sponsor  ICMJE Tampere University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pirkko-Liisa Kellokumpu-Lehtinen, professor Tampere University Hospital
PRS Account Tampere University Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP