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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. Identifier: NCT03189576
Recruitment Status : Active, not recruiting
First Posted : June 16, 2017
Last Update Posted : September 23, 2019
Information provided by (Responsible Party):
Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Residual Disease Diagnostic Test: blood draw Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
CRC patients after primary surgery
sequential blood draw taken to monitor residual disease
Diagnostic Test: blood draw

Primary Outcome Measures :
  1. ctDNA level [ Time Frame: 3-6 months ]
    residual disease measured by sequential blood draws

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • planned colorectal primary surgery

Exclusion Criteria:

  • unfit patients with dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03189576

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Tampere University Hospital
Tampere, Finland, 33520
Sponsors and Collaborators
Tampere University Hospital
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Study Director: Pirkko-Liisa Kellokumpu-Lehtinen, professor Tampere University Hospital
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Responsible Party: Pirkko-Liisa Kellokumpu-Lehtinen, professor, Tampere University Hospital Identifier: NCT03189576    
Other Study ID Numbers: ETL R15085
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm, Residual
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes