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

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ClinicalTrials.gov Identifier: NCT03189576
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Colorectal Cancer Residual Disease Diagnostic Test: blood draw

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
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

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: June 16, 2017    Key Record Dates
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