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

This study is currently recruiting participants.
Verified June 2017 by Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03189576
First Posted: June 16, 2017
Last Update Posted: June 16, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital
  Purpose

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 Intervention
Colorectal Cancer Residual Disease Diagnostic Test: blood draw

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pirkko-Liisa Kellokumpu-Lehtinen, Tampere University Hospital:

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


Estimated Enrollment: 37
Actual Study Start Date: October 1, 2015
Estimated Study Completion Date: August 30, 2021
Estimated Primary Completion Date: August 30, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CRC patients after primary surgery
sequential blood draw taken to monitor residual disease
Diagnostic Test: blood draw

  Eligibility

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.


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

Inclusion Criteria:

  • planned colorectal primary surgery

Exclusion Criteria:

  • unfit patients with dementia
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03189576


Contacts
Contact: Kaisa Lehtomäki, MD +358 331164524 kaisa.lehtomaki@pshp.fi
Contact: Pirkko-Liisa Kellokumpu-Lehtinen, professor klpike@uta.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33520
Contact: Kaisa Lehtomäki, MD         
Sponsors and Collaborators
Tampere University Hospital
Investigators
Study Director: Pirkko-Liisa Kellokumpu-Lehtinen, professor Tampere University Hospital
  More Information

Responsible Party: Pirkko-Liisa Kellokumpu-Lehtinen, professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03189576     History of Changes
Other Study ID Numbers: ETL R15085
First Submitted: June 14, 2017
First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm, Residual
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes