Assessment of Clinically Related Outcomes and Biomarker Analysis for Translational Integration in Colorectal Cancer
NCT ID: NCT01762813
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1200 participants
OBSERVATIONAL
2013-01-01
2027-12-31
Brief Summary
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* Prospective collection of tissues to explore potential biomarkers in blood and/or primary or secondary cancers and/or normal colon
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
open and laparoscopic surgery
Curative surgery for either primary (colorectal cancer, crc) or metastatic CRC (liver surgery)
Interventions
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open and laparoscopic surgery
Curative surgery for either primary (colorectal cancer, crc) or metastatic CRC (liver surgery)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent to participate
* Age ≥18
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Helse Stavanger HF
OTHER_GOV
Responsible Party
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Principal Investigators
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Kjetil Søreide, MD, PhD, FRCS, FACS
Role: PRINCIPAL_INVESTIGATOR
Helse Stavanger HF
Locations
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Stavanger University Hospital
Stavanger, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Study Documents
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Document Type: Study Protocol
View DocumentRelated Links
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ACROBATICC protocol paper
Other Identifiers
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29034/2012
Identifier Type: -
Identifier Source: org_study_id
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