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Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.

NCT04021459CompletedNAINTERVENTIONAL

Summary

The purpose of this study is to investigate the spread of Circulating Tumor Cells (CTC) during surgery in endometrial cancer. Although this cancer is often discovered at early stage, the risk of recurrence is estimated at 6 to 21%, according to grade. Early stage tumor is accessible for curative surgical treatment by laparoscopy but this kind of surgery may induce CTCs spread, and could be an explanation of this recurrence. Through this study, concordance between two blood punction sites, peripheral vein and ovarian vein, will be evaluated to detect these cells during surgery.

Key Facts

Lead Sponsor

University Hospital, Montpellier

Enrollment

Start Date

2019-09-16

Completion Date

2021-09-15

Study Type

INTERVENTIONAL

Official Title

Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery

Interventions

blood samples

Conditions

Endometrial Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Patients with endometrial cancer
* Being affiliated or benefiting from a French social security system

Exclusion Criteria:

* Patients with an other cancer

Outcome Measures

Primary Outcomes

Qualitative assessment

Presence or not of at least one CTC during endometrial cancer surgery detected on two venipuncture site (peripheral and ovarian vein).

Time frame: During surgery (at the ligature of the ovarian ligament)

Secondary Outcomes

Quantitative assessment

Number of CTC detected from each sampling

Time frame: Before surgery and during surgery

Locations

Montpellier University Hospital, Montpellier, France

CHU de Nîmes, Nîmes, France

Linked Papers

2023-02-24

Circulating Tumor Cell Detection by Liquid Biopsy during Early-Stage Endometrial Cancer Surgery: A Pilot Study

The recurrence of non-metastatic endometrial carcinoma (EC) (6 to 21%) might be due to disseminated tumor cells. This feasibility study investigated whether circulating tumor cells (CTCs) were detectable in blood samples from the peripheral and ovarian veins of 10 patients undergoing laparoscopic resection of stage I-II EC between July 2019 and September 2021. CTCs were detected using the CellSearch® system (i) preoperatively (T0) in peripheral blood, (ii) after ovary suspensory ligament pediculation in ovarian vein blood (T1), and (iii) before colpotomy in peripheral blood (T2). CTCs were detected only in ovarian vein samples in 8/10 patients. The CTC median number did not differ with patient age (37 (min-max: 0–91) in <70-year-old vs. 11 (0–65) in ≥70 year-old women, p = 0.59), tumor grade (15 (0–72) for grade 1 vs. 15 (0–91) for grade 2, p = 0.97), FIGO stage (72 (27–91) vs. 2 (0–65) vs. 3 (0–6]) for stage IA, B, and II, respectively; p = 0.08), and tumor size (40 (2–72) for size < 30 mm vs. 4 (0–91) for size ≥ 30 mm, p = 0.39). Estrogen receptor-positive CTCs and CTC clusters were identified. The prognostic and therapeutic values of CTCs released during EC surgery need to be determined.

Linked Investigators

Catherine Alix-Panabières

Professor Catherine Alix-Panabières started her carrier, in 1999, in Montpellier where she did a postdoctoral research at the University Medical Centre. Since 2022, she is also Visiting Professor at the University of Hamburg in Germany. She has optimized new techniques of enrichment, detection and characterization of viable circulating tumor cells (CTCs) in patients with solid tumors. Profs Catherine Alix-Panabières & Pantel coined for the first time the term ‘Liquid Biopsy’ in 2010 (Trends Mol Med). She organized and co-organized many international meetings on liquid biopsy (4 ISMRC), several major Symposium on liquid biopsy at the AACR, ESMO. She has authored or co-authored >135 scientific publications in this field during the last years (h index: 58; 16,273 citations) and 15 book chapters, she is the inventor of three patents in the liquid biopsy field and she is part of French national projects as well as in many European ones. She has many collaborations in Europe, America and Asia. More importantly, she demonstrated for the first time the clinical utility of CTCs in breast cancer in the French STIC-METABREAST group. Finally, she is the expert in the establishment of many permanent CTC lines, in colon and breast cancer.

Laure Cayrefourcq

Martha Duraes

Valérie Macioce