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Influence of the Surgical Technique Used for Colectomies on the Concentration of Circulating Tumor DNA and the Presence of Circulating Tumor Cells: Comparison of the "no Touch" Technic With Either First Clamping of the Mesenteric Vessels or First Mobilization of the Tumor Followed by Clamping. (ADNCHIR)

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ClinicalTrials.gov Identifier: NCT03809403
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Colectomy is the most commonly used therapeutic approach for the treatment of non-metastatic colorectal cancer. This approach is generally very effective however the rate of recurrence and the appearance of metachronous metastasis remains a major problem in the postoperative period. One of the hypothesis that can explain this tumor progression is the dissemination of tumor cells at the time of tumor mobilization. In this work, we wish to verify this hypothesis by comparing two surgical technics used in our department for left or right colectomies: respectively either first section of the mesenteric vessels followed by the mobilization of the tumor or first mobilization of the tumor followed by the section of the mesenteric vessels. To evaluate the dissemination, we will study two disseminations markers that have shown their prognostic value: i) circulating tumor cells (which represent a direct marker of dissemination) and ii) tumor circulating DNA (which is an indirect marker) but has the advantage of being more representative of all tumor clones and therefore the tumor burden released into the blood at the time of surgery).

Condition or disease
Colorectal Cancer

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of the Surgical Technique Used for Colectomies on the Concentration of Circulating Tumor DNA and the Presence of Circulating Tumor Cells: Comparison of the "no Touch" Technic With Either First Clamping of the Mesenteric Vessels or First Mobilization of the Tumor Followed by Clamping.
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Group/Cohort
"No touch" group:
Patients with left sided colic adenocarcinoma who underwent left colectomy with an early ligation of mesenteric vessels
"Mobilisation first" group
patients with right colic adenocarcinoma who underwent right colectomy with early mobilisation of the tumor followed by the ligation of the vessels.



Primary Outcome Measures :
  1. Presence of ctDNA [ Time Frame: Day 1 ]
    Evaluate the presence of ctDNA on D1 postoperatively by comparing the two methods of surgery: "no touch" method and first mobilization of the tumor in patients with colon cancer

  2. Presence of ctDNA [ Time Frame: Day -1 ]
    Evaluate the presence of ctDNA on D-1 postoperatively by comparing the two methods of surgery: "no touch" method and first mobilization of the tumor in patients with colon cancer

  3. Presence of ctDNA [ Time Frame: Day 3 ]
    Evaluate the presence of ctDNA on D3 postoperatively by comparing the two methods of surgery: "no touch" method and first mobilization of the tumor in patients with colon cancer


Secondary Outcome Measures :
  1. Presence of CTC [ Time Frame: Day -1, Day 1 and Day 3 ]
    Evaluate the presence of CTC at D-1, D1 and D3 in peripheral blood by comparing the two methods of surgery between the "no touch" method and first mobilization of the tumor in patients with colon cancer.

  2. MSI status [ Time Frame: Day -1, Day 1 and Day 3 ]
    Determine the MSI status on ctDNA in the postoperative period.


Biospecimen Retention:   Samples With DNA
2 samples of 6ml of peripherical blood


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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, aged over 18 years old and more, undergoing colectomy for non-metastatic adenocarcinoma (stage I, II, III) in the colorectal surgery department at St Antoine Hospital from 01/01/2018 to 1/07/2019 are included in the study. Written consent is obtained at the time of admission.
Criteria

Inclusion Criteria:

  • men and women, aged over18 years old and more
  • colectomy for localized colon adenocarcinoma
  • Adenocarcinoma of the colon stage 1,2,3
  • Patient having signed the consent

Exclusion Criteria:

  • carcinomatosis
  • metastatic tumor
  • pregnancy and breast feeding

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): NCT03809403


Contacts
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Contact: Yann Parc, PU-PH 0149282540 yann.parc@aphp.fr
Contact: Jeremie Lefevre, MD, PhD 0149282540 jeremie.lefevre@aphp.fr

Locations
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France
Department of Digestive Surgery, Hôpital Saint-Antoine Recruiting
Paris, France, 75012
Contact: Yann PARC, PUPH, MD    00 33 1 49 28 25 47    yann.parc@sat.aphp.fr   
Contact: Hélène HERMAND, Degree    00 33 1 49 28 66 80    alex.duval@inserm.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Yann Parc, PU-PH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03809403     History of Changes
Other Study ID Numbers: APHP180453
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: February 2019

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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 Assistance Publique - Hôpitaux de Paris:
Colorectal cancer
Surgical Technic
No touch technic
Circulating Tumor DNA
Circulating Tumor Cells
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplastic Cells, Circulating
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes