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 2016 by Helse Stavanger HF
Information provided by (Responsible Party):
Helse Stavanger HF Identifier:
First received: January 3, 2013
Last updated: April 25, 2016
Last verified: April 2016
  • 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

Condition Intervention
Colorectal Cancer
Procedure: open and laparoscopic 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 2027
Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: open and laparoscopic surgery
Curative surgery for either primary (colorectal cancer, crc) or metastatic CRC (liver surgery)
Other Name: Liver 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 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.

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

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
  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 identifier: NCT01762813

Contact: Ramesh Kajavi, RN 92297672 ext 47
Contact: Martin Watson, MSc

Stavanger University Hospital Recruiting
Stavanger, Norway, 4068
Contact: Kjetil Søreide, MD, PhD    92281557 ext 47   
Principal Investigator: Kjetil Søreide, MD, PhD         
Sponsors and Collaborators
Helse Stavanger HF
Principal Investigator: Kjetil Søreide, MD, PhD Helse Stavanger HF
  More Information

Responsible Party: Helse Stavanger HF Identifier: NCT01762813     History of Changes
Other Study ID Numbers: 29034/2012 
Study First Received: January 3, 2013
Last Updated: April 25, 2016
Health Authority: Norway: Regional Ethics Commitee

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on May 30, 2016