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Trial record 1 of 2 for:    Claus and IMPROVE | Colorectal Cancer | Denmark
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Circulating Tumor DNA Analysis to Optimize Treatment for Patients With Colorectal Cancer (IMPROVE)

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ClinicalTrials.gov Identifier: NCT03637686
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The overall objective of these studies are to confirm that ctDNA detected in plasma after intended curative treatment for CRC can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.

Condition or disease
Colorectal Cancer

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer
Actual Study Start Date : June 14, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Patients with high risk of recurrence can be identified with ctDNA profiling performed immediately after treatment for CRC. [ Time Frame: 3 years ]
    3-year disease-free survival (3y-DFS)


Secondary Outcome Measures :
  1. Association between ctDNA and the quality of primary surgery - the plane of the surgery [ Time Frame: 3 years ]
    Association between presence of ctDNA measured by sequencing cfDNA and the plane of the surgery in the pathological specimen (muscular, intrameso-colic/rectal, meso-colic/rectal)

  2. Association between ctDNA and the quality of primary surgery - the level of resection of the tumor feeding arteries [ Time Frame: 1 years ]
    Association between presence of ctDNA measured by sequencing cfDNA and the length of the feeding artery in the resection specimen and the length of the artery residue in the patient measured on the first follow-up CT scan (at 12 month post-OP), respectively.

  3. ctDNA profiling for evaluating quality improvement of surgery - before and after implementation of of a training program [ Time Frame: 3 years ]
    ctDNA is measured by sequencing cfDNA. The rate of detection of ctDNA post-operatively is compared between resections performed before and after implementation of the training program at five Danish surgical centers.

  4. ctDNA profiling for evaluating quality improvement of surgery - between centers with and without implementation of the training program [ Time Frame: 3 years ]
    ctDNA is measured by sequencing cfDNA. The rate of detection of ctDNA post-operatively is compared between resections performed at centers with and without implementation of the training program.

  5. Association between ctDNA and the effect of adjuvant chemotherapy [ Time Frame: 3 years ]
    ctDNA measured by sequencing cfDNA. ctDNA measurements are performed before and after adjuvant chemotherapy. Changes in ctDNA level will be correlated to oncological outcome by measuring time to clinical recurrence, disease-free survival and overall survival.

  6. Can ctDNA detect recurrence earlier than standard-of-care? [ Time Frame: 7 years ]
    The difference between time to molecular recurrence (ctDNA detection) is compared to the time to clinical recurrence measured on CT scans..


Biospecimen Retention:   Samples With DNA
Tissue Plasma Serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All patients with stage I-III colon or rectal cancer, scheduled for curative intended resectional surgery.
Criteria

Part I: Surgery

Inclusion Criteria:

  • Colon or rectal cancer, clinical tumor stage I-III
  • Patient able to understand and sign written informed consent
  • Scheduled for curative intended resectional surgery

Exclusion Criteria:

  • Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
  • Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  • Verified distant metastases
  • Malignant colorectal polyps diagnosed after polypectomy
  • Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study

Part II: Surveillance:

Inclusion criteria:

One of the following:

  • TNM stage III CRC,
  • or TNM stage II CRC and risk factors qualifying for adjuvant chemotherapy,
  • or TNM stage I or stage II CRC without risk factors, but ctDNA positive in the post-operative day14 plasma sample. Inclusion requires that the patient declined participation in the IMPROVE IT trial.

Exclusion criteria:

  • Synchronous colorectal and non-colorectal cancer diagnosed per-operative (except skin cancer other than melanoma)
  • Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637686


Contacts
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Contact: Claus L Andersen, PhD +45 78455319 cla@clin.au.dk
Contact: Christina Demuth, PhD +45 78455325 demuth@clin.au.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, North Denmark Region, Denmark, 9000
Contact: Ole Thorlacius-Ussing, MD, PhD       otu@rn.dk   
Odense University Hospital Recruiting
Odense, The Region Of Southern Denmark, Denmark, 5000
Contact: Per Vadgaard Andersen, MD, PhD       Per.vadgaard.andersen@rsyd.dk   
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Lene H Iversen, MD, PhD       lene.h.iversen@dadlnet.dk   
Regional Hospital West Jutland Recruiting
Herning, Denmark, 7400
Contact: Anders H Madsen, MD, PhD       andemads@rm.dk   
Regional Hospital Randers Recruiting
Randers, Denmark, 8930
Contact: Kåre G Sunesen, MD, PhD       kaarsune@rm.dk   
Regional Hospital Viborg Recruiting
Viborg, Denmark, 8800
Contact: Uffe S Løve, MD, PhD       uffescho@rm.dk   
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Principal Investigator: Claus L Andersen, PhD University of Aarhus
Principal Investigator: Søren Laurberg, MD, PhD Aarhus University Hospital
Principal Investigator: Karen-Lise G Spindler, MD, PhD Aarhus University Hospital

Publications:
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03637686     History of Changes
Other Study ID Numbers: IMPROVE
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Colorectal cancer
Circulating tumor DNA

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases