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Colorectal CancerACROBATICCNCT01762813

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

An observational study of Colorectal Cancer, run by Helse Stavanger HF at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
open and laparoscopic surgery
Type of treatment
Surgery or procedure
How many people
1,200 participants
Where
1 siteNorway
Study dates
1 Jan 2013to 31 Dec 2036
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • failure to provide written informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ramesh L. Kajavi, RN contact

92297672 ext. 47

acro.gitan@gmail.com

Marina Alexeeva, PhD contact

marina.alexeeva@sus.no

Norway1 site, 1 recruiting

  • Stavanger University Hospital

    Stavanger, 4068

    Kjetil Søreide, MD, PhD, 92281557 ext. 47, ksoreide@mac.com

    Kjetil Søreide, MD, PhD

    Recruiting

Other trials in Norway

About this study

Official title: 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
Read the 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.

Being tested
open and laparoscopic surgery
Keywords
Colon cancer, rectal cancer, liver metastasis, survival, biomarker, molecular profile
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • open and laparoscopic surgeryProcedure or surgery

    Also called Liver surgery

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

Study groups in NCT01762813
Study groupRoleWhat they receive
open and laparoscopic surgeryPatients 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.
Receives: Procedure: open and laparoscopic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cancer-specific survival

    Time from surgery to death of cancer

    Measured: 5-years

Secondary outcomes (1)

  1. Recurrence-free survival

    Time from surgery to recurrence of cancer

    Measured: 3 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2013 (estimated)
  2. Study start1 Jan 2013
  3. Primary completion31 Dec 2035 (estimated)
  4. Study completion31 Dec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01762813
Sponsor's protocol ID
29034/2012
Acronym
ACROBATICC
Status last verified
Apr 2026
First submitted
3 Jan 2013
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: Raw data may be provided given appropriate consent and approval for anonymous database sharing

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 41372018

  • 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.

    PubMed 39738901

  • 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.

    PubMed 39662106

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Helse Stavanger HF at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ramesh L. Kajavi, RN (92297672 ext. 47, acro.gitan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer-specific survival (time frame: 5-years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01762813, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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