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

This study is currently recruiting participants.
Verified March 2017 by Helse Stavanger HF
Sponsor:
ClinicalTrials.gov Identifier:
NCT01762813
First Posted: January 8, 2013
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Helse Stavanger HF
  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

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 ]

Secondary Outcome Measures:
  • Recurrence-free survival [ Time Frame: 3 and 5 years ]

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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, 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762813


Contacts
Contact: Ramesh Kajavi, RN 92297672 ext 47 acro.gitan@gmail.com
Contact: Martin Watson, MSc martin.watson@sus.no

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

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01762813     History of Changes
Other Study ID Numbers: 29034/2012
First Submitted: January 3, 2013
First Posted: January 8, 2013
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Raw data may be provided given appropriate consent and approval for anonymous database sharing

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