Assessment of Clinically Related Outcomes and Biomarker Analysis for Translational Integration in Colorectal Cancer

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: open and laparoscopic surgery

• Registration Number: NCT01762813
• Lead Sponsor: Helse Stavanger HF

Brief Summary

* A prospective, observational study on clinical outcomes of surgical management of primary and metastatic colorectal cancer

* Prospective collection of tissues to explore potential biomarkers in blood and/or primary or secondary cancers and/or normal colon

Detailed Description

Prospective project in collecting and assessing clinical outcomes data related to molecular profiling of tumors based on cancer primary or metastatic tissue or tissue from peripheral blood samples. As a future part of the project will be collected patient reported outcomes (PROs) for assessing clinical outcomes in relation to clinical pathways, patient reported results, as well as tumor profiling by molecular methods.

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Diagnosis of colorectal cancer, primary or metastatic (liver), with a treatment intention of planned curative surgery
• Informed consent to participate
• Age ≥18

Exclusion Criteria

• failure to provide written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
open and laparoscopic surgery	open and laparoscopic surgery	Patients with primary and or metastatic colorectal cancer (CRC) eligible for curative surgery will be included. Subcohorts may be based on either colon cancer, rectal cancer, metastatic cancer, surgery (laparoscopy or open), node negative and node positive disease, and molecular profiling.

Primary Outcome Measures

Name	Time	Method
Cancer-specific survival	5-years	Time from surgery to death of cancer

Secondary Outcome Measures

Name	Time	Method
Recurrence-free survival	3 and 5 years	Time from surgery to recurrence of cancer

Trial Locations

Locations (1)

Stavanger University Hospital; 🇳🇴 Stavanger, Norway