NCT03189576

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

7.9 years

First QC Date

June 14, 2017

Last Update Submit

May 25, 2023

Conditions

Colorectal CancerResidual Disease

Outcome Measures

Primary Outcomes (1)

  • ctDNA level

    residual disease measured by sequential blood draws

    3-6 months

Study Arms (1)

CRC patients after primary surgery

OTHER

sequential blood draw taken to monitor residual disease

Diagnostic Test: blood draw

Interventions

blood drawDIAGNOSTIC_TEST
CRC patients after primary surgery

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • planned colorectal primary surgery

You may not qualify if:

  • unfit patients with dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33520, Finland

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm, Residual

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pirkko-Liisa Kellokumpu-Lehtinen, professor

    Tampere University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

October 1, 2015

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)