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

Sponsor

Tampere University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03189576

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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	Phase
Colorectal Cancer Residual Disease	Diagnostic Test: blood draw	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2015

Anticipated Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Aug 30, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Other: CRC patients after primary surgery

sequential blood draw taken to monitor residual disease

Diagnostic Test: blood draw

Outcome Measures

Primary Outcome Measures

ctDNA level [3-6 months]
residual disease measured by sequential blood draws

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

planned colorectal primary surgery

Exclusion Criteria:

unfit patients with dementia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampere University Hospital	Tampere		Finland	33520

Sponsors and Collaborators

Tampere University Hospital

Investigators

Study Director: Pirkko-Liisa Kellokumpu-Lehtinen, professor, Tampere University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pirkko-Liisa Kellokumpu-Lehtinen, professor, Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT03189576

Other Study ID Numbers:

ETL R15085

First Posted:

Jun 16, 2017

Last Update Posted:

Oct 27, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Neoplasm, Residual

Study Results

No Results Posted as of Oct 27, 2020