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.

NCT03809403 | Unknown

• 1 other identifier: APHP180453
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Surgical Technic; No touch technic; Circulating Tumor DNA; Circulating Tumor Cells

Outcome Measures

Primary Outcomes (3)

• Presence of ctDNA

  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

  Day 1

• Presence of ctDNA

  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

  Day -1

• Presence of ctDNA

  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

  Day 3

Secondary Outcomes (2)

• Presence of CTC

  Day -1, Day 1 and Day 3

• MSI status

  Day -1, Day 1 and Day 3

Study Arms (2)

"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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• carcinomatosis
• metastatic tumor
• pregnancy and breast feeding

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Department of Digestive Surgery, Hôpital Saint-Antoine

Paris, 75012, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

2 samples of 6ml of peripherical blood

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• Yann Parc, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yann Parc, PU-PH

CONTACT

0149282540; yann.parc@aphp.fr

Jeremie Lefevre, MD, PhD

CONTACT

0149282540; jeremie.lefevre@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 18, 2019
• Study Start: February 5, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-02

Locations

FR (1)