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

Colorectal Cancer Clinical Trial

— ACROBATICC  

Official title:

Prospective, Population-based Cohort Collection of Blood Samples and Tumor Tissue From Patients Operated on for Primary or Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01762813
• Other study ID #: 29034/2012
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2019
• Source: Helse Stavanger HF
• Contact: Tone L. Klaening, RN
• Phone: 92297672
• Email: acro.gitan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• open and laparoscopic surgery
Curative surgery for either primary (colorectal cancer, crc) or metastatic CRC (liver surgery)

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Hagland HR, Lea D, Watson MM, Søreide K. Correlation of Blood T-Cells to Intratumoural Density and Location of CD3(+) and CD8(+) T-Cells in Colorectal Cancer. Anticancer Res. 2017 Feb;37(2):675-683. — View Citation

Søreide K, Watson MM, Lea D, Nordgård O, Søreide JA, Hagland HR; ACROBATICC collaborators. Assessment of clinically related outcomes and biomarker analysis for translational integration in colorectal cancer (ACROBATICC): study protocol for a population-based, consecutive cohort of surgically treated colorectal cancers and resected colorectal liver metastasis. J Transl Med. 2016 Jun 29;14(1):192. doi: 10.1186/s12967-016-0951-4. — View Citation

Watson MM, Kanani A, Lea D, Khajavi RB, Søreide JA, Kørner H, Hagland HR, Søreide K. Elevated Microsatellite Alterations at Selected Tetranucleotides (EMAST) in Colorectal Cancer is Associated with an Elderly, Frail Phenotype and Improved Recurrence-Free — View Citation

Watson MM, Lea D, Hagland HR, Søreide K. Elevated Microsatellite Alterations at Selected Tetranucleotides (EMAST) Is Not Attributed to MSH3 Loss in Stage I-III Colon cancer: An Automated, Digitalized Assessment by Immunohistochemistry of Whole Slides and — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-specific survival	Time from surgery to death of cancer	5-years
Secondary	Recurrence-free survival	Time from surgery to recurrence of cancer	3 and 5 years

External Links

•   ACROBATICC protocol paper