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

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

• 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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: open and laparoscopic 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.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Ramesh L. Kajavi, RN; Phone Number: 47 92297672; Email: acro.gitan@gmail.com
• Study Contact Backup: Name: Marina Alexeeva, PhD; Email: marina.alexeeva@sus.no

Study Locations

• Norway
  • Stavanger, Norway, 4068
    • Recruiting
    • Stavanger University Hospital
    • Contact: Kjetil Søreide, MD, PhD; Phone Number: 47 92281557; Email: ksoreide@mac.com
    • Principal Investigator: Kjetil Søreide, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: Liver surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer-specific survival	Time from surgery to death of cancer	5-years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival	Time from surgery to recurrence of cancer	3 and 5 years

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Investigators: Principal Investigator: Kjetil Søreide, MD, PhD, FRCS, FACS, Helse Stavanger HF

Publications and helpful links

General Publications

• Soreide K, Watson MM, Lea D, Nordgard O, Soreide 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.
• Hagland HR, Lea D, Watson MM, Soreide 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. doi: 10.21873/anticanres.11363.
• Watson MM, Lea D, Hagland HR, Soreide 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 Hot Spots. Transl Oncol. 2019 Dec;12(12):1583-1588. doi: 10.1016/j.tranon.2019.08.009. Epub 2019 Oct 31.
• Watson MM, Kanani A, Lea D, Khajavi RB, Soreide JA, Korner H, Hagland HR, Soreide K. Elevated Microsatellite Alterations at Selected Tetranucleotides (EMAST) in Colorectal Cancer is Associated with an Elderly, Frail Phenotype and Improved Recurrence-Free Survival. Ann Surg Oncol. 2020 Apr;27(4):1058-1067. doi: 10.1245/s10434-019-08048-6. Epub 2019 Nov 4.
• Lea D, Zaharia C, Soreide K. Programmed death ligand-1 (PD-L1) clone 22C3 expression in resected colorectal cancer as companion diagnostics for immune checkpoint inhibitor therapy: A comparison study and inter-rater agreement evaluation across proposed cut-offs and predictive (TPS, CPS and IC) scores. Cancer Treat Res Commun. 2024;38:100788. doi: 10.1016/j.ctarc.2023.100788. Epub 2023 Dec 22.
• Watson MM, Lea D, Gudlaugsson E, Skaland I, Hagland HR, Soreide K. Prevalence of PD-L1 expression is associated with EMAST, density of peritumoral T-cells and recurrence-free survival in operable non-metastatic colorectal cancer. Cancer Immunol Immunother. 2020 Aug;69(8):1627-1637. doi: 10.1007/s00262-020-02573-0. Epub 2020 Apr 20.
• Veen T, Kanani A, Alvestad AB, Edland KH, Lea D, Soreide K. Rectal cancer with synchronous liver metastasis undergoing hepatectomy: sequencing to the 'liver-first' reflects tumour burden of the primary. Surg Oncol. 2026 Mar 23;66:102413. doi: 10.1016/j.suronc.2026.102413. Online ahead of print.
• Veen T, Lea D, Roalso M, Soreide K. Repeat hepatectomy for colorectal liver metastasis with rates of second and third hepatectomy: time-to-recurrence and overall survival in a population-derived cohort. HPB (Oxford). 2026 Feb;28(2):189-198. doi: 10.1016/j.hpb.2025.11.006. Epub 2025 Nov 14.
• Kanani A, Veen T, Lea D, Zaharia C, Watson M, Alexeeva M, Thorsen K, Soreide K. Neoadjuvant Immunotherapy Followed by Surgery Compared with Upfront Surgery Alone in Operable Colon Cancer with Deficient Mismatch Repair: Modeling Oncological Outcomes and Numbers Needed to Treat. Ann Surg Oncol. 2025 May;32(5):3068-3077. doi: 10.1245/s10434-024-16755-y. Epub 2024 Dec 30.
• Veen T, Kanani A, Zaharia C, Lea D, Soreide K. Treatment-sequencing before and after index hepatectomy with either synchronous or metachronous colorectal liver metastasis: Comparison of recurrence risk, repeat hepatectomy and overall survival in a population-derived cohort. Eur J Surg Oncol. 2025 Feb;51(2):109540. doi: 10.1016/j.ejso.2024.109540. Epub 2024 Dec 9.

Helpful Links

• ACROBATICC protocol paper

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2036

Study Registration Dates

• First Submitted: January 3, 2013
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (Estimated): January 8, 2013

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: biomarker; survival; rectal cancer; liver metastasis; Colon cancer; molecular profile
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Rectal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Laparoscopy
• Other Study ID Numbers: 29034/2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Raw data may be provided given appropriate consent and approval for anonymous database sharing

Study Data/Documents

1. Study Protocol