NCT01762813

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
127mo left

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jan 2013Dec 2036

Study Start

First participant enrolled

January 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
23 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2036

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

23 years

First QC Date

January 3, 2013

Last Update Submit

April 25, 2026

Conditions

Keywords

Colon cancerrectal cancerliver metastasissurvivalbiomarkermolecular profile

Outcome Measures

Primary Outcomes (1)

  • Cancer-specific survival

    Time from surgery to death of cancer

    5-years

Secondary Outcomes (1)

  • Recurrence-free survival

    3 and 5 years

Study Arms (1)

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

Interventions

Curative surgery for either primary (colorectal cancer, crc) or metastatic CRC (liver surgery)

Also known as: Liver surgery
open and laparoscopic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Diagnosis of colorectal cancer, primary or metastatic (liver), with a treatment intention of planned curative surgery
  • Informed consent to participate
  • Age ≥18

You may not qualify if:

  • failure to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, 4068, Norway

RECRUITING

Related Publications (10)

  • 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.

    PMID: 27357108BACKGROUND
  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Kjetil Søreide, MD, PhD, FRCS, FACS

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramesh L. Kajavi, RN

CONTACT

Marina Alexeeva, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 8, 2013

Study Start

January 1, 2013

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2036

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations