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Clinical Trials/NCT04130971
NCT04130971RecruitingNot Applicable

Predict - a Translational Study to Predict Tumour Response to Neoadjuvant Treatment

Sahlgrenska University Hospital, Sweden1 site in 1 country800 target enrollmentStarted: February 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
800
Locations
1
Primary Endpoint
Tumour response to treatment

Study Overview

Brief Summary

All adult patients with colorectal cancer presenting within the Sahlgrenska University Hospital or treated at any time at Sahlgrenska University Hospital are eligible and will be asked to participate. We already have biopsies taken at surgery in patients that receive surgery, but this study will include all patients and the biopsies will be taken during endoscopy for diagnosis of the primary tumour. Biopsies will then be taken during follow-up exams prior surgery but after neoadjuvant treatment. Biopsies will also be taken during surgery and in cases where surgery is not necessary biopsies will be taken regularly during follow-up exams.

Blood samples and in relevant cases urinary samples and mouth swabs will be taken at all timepoints when biopsies are taken. If it is not possible to take biopsies prior treatment blood samples will still be drawn.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Colorectal cancer

Exclusion Criteria

  • Not colorectal cancer

Outcomes

Primary Outcomes

Tumour response to treatment

Time Frame: 1-2 months after initiated treatment

Tumour microenviroment changes

Secondary Outcomes

  • Normal tissue response to treatment(1month -3 years after treatment)

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eva Angenete

PI

Sahlgrenska University Hospital, Sweden

Study Sites (1)

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