Menu
Recruiting NCT01762813

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

Observational Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: open and laparoscopic surgery.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

* 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

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.

Interventions

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

Primary outcome measures

  • Cancer-specific survival [Time frame: 5-years]
Secondary outcome measures (1)
  • Recurrence-free survival [Time frame: 3 and 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Norway · 1 center
  • Stavanger University Hospital — Stavanger

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. d PMID 27357108
  • 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. PMID 28179316
  • 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. PMID 31677491
  • 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. PMID 31686344
  • 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. PMID 38150845
  • 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. PMID 32314040
  • 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 Jun;66:102413. doi: 10.1016/j.suronc.2026.102413. Epub 2026 Mar 23. PMID 41886837
  • 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. PMID 41372018

Identifiers

NCT: NCT01762813 · 29034/2012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗