Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer (TILsOV-1805)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03922776
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:
This is a monocenter, interventional, non-randomized study among women patients with an ovarian or tubal cancer who will receive a surgery or adjuvant chemotherapy treatment, or a neo-adjuvant chemotherapy then surgery +/- adjuvant chemotherapy. The planned interventions are collection of biological samples at different times. The study will aim to describe the immunological profile at diagnosis in terms of phenotypic : PBMCs (peripheral blood, mononuclear cells) in peripheral blood, TILs (tumor-infiltrating lymphocytes) in ascites and in carcinomatosis.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Stage IIIC Fallopian Tube Cancer Stage IIIC Fallopian Tube Cancer Stage IV Ovarian Cancer Stage IV Procedure: Blood sample collection Not Applicable

Detailed Description:

Participants will receive the following interventions because they are enrolled in the study: blood sample collection

  • at diagnosis, before chemotherapy (pre-CT)
  • after chemotherapy (post-ct)

Two additional blood samples will be collected in each patient : one at diagnosis and one at the end of chemotherapy.

The aim of this study is to describe the immunological profile at diagnosis in terms of phenotypic : PBMC in peripheral blood, TILs in ascites and in carcinomatosis, in patients treated for peritoneal carcinomatosis of ovarian or tubal origin. The treatment has to be a surgery and an adjuvant chemotherapy, or a neo-adjuvant chemotherapy followed by a surgery +/- adjuvant chemotherapy.

Other objectives of the study include:

  • Evaluate the association between the immunological profile at diagnosis and the characteristics of the disease at diagnosis (histological type, extension)
  • Evaluate the prognostic value of the immunological profile at diagnosis in terms of clinical response to neoadjuvant chemotherapy (for patients with interval surgery)
  • Evaluate the polarization of the immune response induced by chemotherapy, describing the phenotypic changes in the different types of samples (blood, +/- ascites, +/- carcinomatosis) after chemotherapy in comparison with samples at diagnostic
  • Evaluate the association between these immunological phenotypic changes and the clinical response to chemotherapy in patients receiving neoadjuvant chemotherapy
  • Collect biological material for peritoneal carcinomatosis for subsequent biological analyzes

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Advanced High-grade Serous Ovarian Cancer in Blood, Ascites, Peritoneal Biopsy
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Blood sample collection

Participants will receive the following interventions because they are enrolled in the study: blood sample collection

  • at diagnosis, before chemotherapy (pre-CT)
  • after chemotherapy (post-ct)

Intervention : Collection of two blood samples (5mL)

  • before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment
  • and then, after chemotherapy (post-CT), up to 3 months after enrollment
Procedure: Blood sample collection

Participants will receive the following interventions because they are enrolled in the study: blood sample collection

  • at diagnosis, before chemotherapy (pre-CT)
  • after chemotherapy (post-ct) Collection of two blood samples (5mL),
  • before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment
  • and then, after chemotherapy (post-CT), up to 3 months after enrollment




Primary Outcome Measures :
  1. Counting of lymphocyte populations (pre-chemotherapy) [ Time Frame: At diagnosis (during diagnostic laparoscopy, which is : before chemotherapy (pre-CT) and up to 1 month after enrollment) ]
    For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), before chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint

  2. Counting of lymphocyte populations (post-chemotherapy) [ Time Frame: At the end of chemotherapy (post-CT), up to 3 months ]
    For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), at the end of chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint


Secondary Outcome Measures :
  1. Histological type on the initial biopsy [ Time Frame: At diagnosis, before chemotherapy (pre-CT), up to 1 month after enrollment ]
    To check if there is an extension to the pleura (FIGO-IV) or not (FIGO-IIIC)

  2. Clinical response to chemotherapy (post-chemotherapy) [ Time Frame: At the end of chemotherapy, up to 3 months ]
    In patients receiving neo-adjuvant chemotherapy, clinical response to chemotherapy defined by a partial or complete radiological response (assessed on the thoraco-abdominopelvic CT scan), associated with a decrease in CA125 and a disappearance of ascites in case of ascites at inclusion

  3. Histological response to chemotherapy (no residual disease on excised tissue) [ Time Frame: At the surgery, an average of 6 weeks after inclusion ]
    Rate of patients with no residual disease on excised tissue regarding the assessment of histological response to chemotherapy

  4. Progression-free survival [ Time Frame: 6 months min to 14 months max ]
    Time between the diagnosis and the progression of the disease or the death of the patient, whatever the cause

  5. Global survival [ Time Frame: 6 months min to 14 months max ]
    Time between diagnosis and death, whatever the cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women in a study of ovarian cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old or more
  • Presenting a carcinomatosis with suspicion of ovarian cancer or tubal cancer, under a diagnostic laparoscopy
  • Stage IIIC or initial pleural IV
  • Planned treatment with surgery and adjuvant chemotherapy, or neo-adjuvant chemotherapy followed by surgery +/- adjuvant chemotherapy
  • Having been informed and signed the informed consent of this study
  • Affiliated with a social security scheme

Exclusion Criteria:

  • Stage IV with visceral metastases (pulmonary, hepatic ...)
  • Contraindication to surgery and / or chemotherapy
  • Pregnant or lactating woman
  • Patient under guardianship or curatorship

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): NCT03922776


Contacts
Layout table for location contacts
Contact: Marie Vanseymortier 03 20 29 59 18 promotion@o-lambret.fr
Contact: Delphine Hudry, MD 03.20.29.59.59 d-hudry@o-lambret.fr

Locations
Layout table for location information
France
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Delphine DH Hudry, MD    03 20 29 59 59    d-hudry@o-lambret.fr   
Sub-Investigator: Eric EL Leblanc, MD         
Sub-Investigator: Fabrice FN Narducci, MD         
Sub-Investigator: Cyril CA Abdeddaim, MD         
Sub-Investigator: Annick AC Chevalier, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Layout table for investigator information
Principal Investigator: Delphine Hudry, MD Département de cancérologie uro-digestive - Centre Oscar Lambret

Publications:
Ovarian Tumor Tissue Analysis (OTTA) Consortium, Goode EL, Block MS, Kalli KR, Vierkant RA, Chen W, Fogarty ZC, Gentry-Maharaj A, Tołoczko A, Hein A, Bouligny AL, Jensen A, Osorio A, Hartkopf A, Ryan A, Chudecka-Głaz A, Magliocco AM, Hartmann A, Jung AY, Gao B, Hernandez BY, Fridley BL, McCauley BM, Kennedy CJ, Wang C, Karpinskyj C, de Sousa CB, Tiezzi DG, Wachter DL, Herpel E, Taran FA, Modugno F, Nelson G, Lubiński J, Menkiszak J, Alsop J, Lester J, García-Donas J, Nation J, Hung J, Palacios J, Rothstein JH, Kelley JL, de Andrade JM, Robles-Díaz L, Intermaggio MP, Widschwendter M, Beckmann MW, Ruebner M, Jimenez-Linan M, Singh N, Oszurek O, Harnett PR, Rambau PF, Sinn P, Wagner P, Ghatage P, Sharma R, Edwards RP, Ness RB, Orsulic S, Brucker SY, Johnatty SE, Longacre TA, Ursula E, McGuire V, Sieh W, Natanzon Y, Li Z, Whittemore AS, Anna A, Staebler A, Karlan BY, Gilks B, Bowtell DD, Høgdall E, Candido dos Reis FJ, Steed H, Campbell IG, Gronwald J, Benítez J, Koziak JM, Chang-Claude J, Moysich KB, Kelemen LE, Cook LS, Goodman MT, García MJ, Fasching PA, Kommoss S, Deen S, Kjaer SK, Menon U, Brenton JD, Pharoah PDP, Chenevix-Trench G, Huntsman DG, Winham SJ, Köbel M, Ramus SJ. Dose-Response Association of CD8+ Tumor-Infiltrating Lymphocytes and Survival Time in High-Grade Serous Ovarian Cancer. JAMA Oncol. 2017 Dec 1;3(12):e173290. doi: 10.1001/jamaoncol.2017.3290.
Galluzzi L, Vacchelli E, Bravo-San Pedro JM, Buqué A, Senovilla L, Baracco EE, Bloy N, Castoldi F, Abastado JP, Agostinis P, Apte RN, Aranda F, Ayyoub M, Beckhove P, Blay JY, Bracci L, Caignard A, Castelli C, Cavallo F, Celis E, Cerundolo V, Clayton A, Colombo MP, Coussens L, Dhodapkar MV, Eggermont AM, Fearon DT, Fridman WH, Fučíková J, Gabrilovich DI, Galon J, Garg A, Ghiringhelli F, Giaccone G, Gilboa E, Gnjatic S, Hoos A, Hosmalin A, Jäger D, Kalinski P, Kärre K, Kepp O, Kiessling R, Kirkwood JM, Klein E, Knuth A, Lewis CE, Liblau R, Lotze MT, Lugli E, Mach JP, Mattei F, Mavilio D, Melero I, Melief CJ, Mittendorf EA, Moretta L, Odunsi A, Okada H, Palucka AK, Peter ME, Pienta KJ, Porgador A, Prendergast GC, Rabinovich GA, Restifo NP, Rizvi N, Sautès-Fridman C, Schreiber H, Seliger B, Shiku H, Silva-Santos B, Smyth MJ, Speiser DE, Spisek R, Srivastava PK, Talmadge JE, Tartour E, Van Der Burg SH, Van Den Eynde BJ, Vile R, Wagner H, Weber JS, Whiteside TL, Wolchok JD, Zitvogel L, Zou W, Kroemer G. Classification of current anticancer immunotherapies. Oncotarget. 2014 Dec 30;5(24):12472-508. Review.

Layout table for additonal information
Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT03922776     History of Changes
Other Study ID Numbers: TILsOV-1805
Id RCB ( Registry Identifier: 2018-A00771-54 )
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Oscar Lambret:
Ovarian cancer
Tubal Cancer
Immunological profile
PBMc
TILs
Carcinomatosis
HGSOC

Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases