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

NCT ID: NCT01762813

Last Updated: 2024-07-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2027-12-31

Brief Summary

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* 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

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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.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type PROCEDURE

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)

Intervention Type PROCEDURE

Other Intervention Names

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Liver surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Ramesh L. Kajavi, RN

Role: CONTACT

92297672 ext. 47

Marina Alexeeva, PhD

Role: CONTACT

Facility Contacts

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Kjetil Søreide, MD, PhD

Role: primary

92281557 ext. 47

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.

Reference Type BACKGROUND
PMID: 27357108 (View on PubMed)

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.

Reference Type RESULT
PMID: 28179316 (View on PubMed)

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.

Reference Type RESULT
PMID: 31677491 (View on PubMed)

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.

Reference Type RESULT
PMID: 31686344 (View on PubMed)

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.

Reference Type RESULT
PMID: 38150845 (View on PubMed)

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.

Reference Type RESULT
PMID: 32314040 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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29034/2012

Identifier Type: -

Identifier Source: org_study_id

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