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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Helse Stavanger HF
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01762813
First received: January 3, 2013
Last updated: April 5, 2014
Last verified: April 2014
  Purpose
  • 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
  • Prospective collection of patient reported outcome measures (PROMs)

Condition Intervention
Colorectal Cancer
Procedure: Colorectal cancer surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Population-based Cohort Collection of Blood Samples and Tumor Tissue From Patients Operated on for Primary or Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Cancer-specific survival [ Time Frame: 5-years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence-free survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, whole blood, plasma, cancer tissue, normal tissue


Estimated Enrollment: 850
Study Start Date: August 2012
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
colorectal cancer surgery
Patients with primary and or metastic colorectal cancer eligible for curative surgery will be included. Subcohorts may be based on either colon cancer, rectal cancer, metastatic cancer, surgery, node negative and node positive disease, and molecular profiling.
Procedure: Colorectal cancer surgery
Curative surgery for either primary (colorectal cancer) or metastatic CRC (liver surgery)
Other Name: Liver metastasis surgery

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with colorectal cancer (primary and/or secondary) undergoing surgery for curative intent

Criteria

Inclusion Criteria:

  • Diagnosis of colorectal cancer
  • Informed consent to participate
  • Age ≥18

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762813

Contacts
Contact: Hanne R. Hagland, PhD 92297672 ext 47 hannehagland@gmail.com
Contact: Marianne Berg, PhD 91106328 ext 47 marianne@marianneberg.com

Locations
Norway
Stavanger University Hospital Recruiting
Stavanger, Norway, 4068
Contact: Kjetil Søreide, MD, PhD    92281557 ext 47    ksoreide@mac.com   
Principal Investigator: Kjetil Søreide, MD, PhD         
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: Kjetil Søreide, MD, PhD Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01762813     History of Changes
Other Study ID Numbers: 29034/2012
Study First Received: January 3, 2013
Last Updated: April 5, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Helse Stavanger HF:
Colon cancer
rectal cancer
liver metastasis
survival
biomarker
molecular profile

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 23, 2014