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Ovarian Cancer Stage IIICTILsOVNCT03922776

Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer

A study testing Blood sample collection in people with Ovarian Cancer Stage IIIC and Fallopian Tube Cancer Stage IIIC, run by Centre Oscar Lambret at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Blood sample collection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteFrance
Study dates
17 May 2019to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Oscar Lambret

    Lille, France, 59020

Other trials in France

About this study

Official title: Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Advanced High-grade Serous Ovarian Cancer in Blood, Ascites, Peritoneal Biopsy

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.

Read the 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
Being tested
Blood sample collection
Keywords
Ovarian cancer, Tubal Cancer, Immunological profile, PBMc, TILs, Carcinomatosis, HGSOC
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sample collectionProcedure or surgery

    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
Study groups in NCT03922776
Study groupRoleWhat they receive
Blood sample collectionExperimentalParticipants 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
Receives: Procedure: Blood sample collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Counting of lymphocyte populations (pre-chemotherapy)

    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

    Measured: At diagnosis (during diagnostic laparoscopy, which is : before chemotherapy (pre-CT) and up to 1 month after enrollment)

  2. Counting of lymphocyte populations (post-chemotherapy)

    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

    Measured: At the end of chemotherapy (post-CT), up to 3 months

Secondary outcomes (5)

  1. Histological type on the initial biopsy

    To check if there is an extension to the pleura (FIGO-IV) or not (FIGO-IIIC)

    Measured: At diagnosis, before chemotherapy (pre-CT), up to 1 month after enrollment

  2. Clinical response to chemotherapy (post-chemotherapy)

    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

    Measured: At the end of chemotherapy, up to 3 months

  3. Histological response to chemotherapy (no residual disease on excised tissue)

    Rate of patients with no residual disease on excised tissue regarding the assessment of histological response to chemotherapy

    Measured: At the surgery, an average of 6 weeks after inclusion

  4. Progression-free survival

    Time between the diagnosis and the progression of the disease or the death of the patient, whatever the cause

    Measured: 6 months min to 14 months max

  5. Global survival

    Time between diagnosis and death, whatever the cause

    Measured: 6 months min to 14 months max

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2019
  2. Study start17 May 2019
  3. Primary completion31 May 2024
  4. Study completion31 Jul 2024

Why it stopped: End of recruiting period

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03922776
Sponsor's protocol ID
TILsOV-1805
Other IDs
2018-A00771-54
Acronym
TILsOV
Status last verified
Mar 2026
First submitted
30 Jan 2019
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bobisse S, Genolet R, Roberti A, Tanyi JL, Racle J, Stevenson BJ, Iseli C, Michel A, Le Bitoux MA, Guillaume P, Schmidt J, Bianchi V, Dangaj D, Fenwick C, Derre L, Xenarios I, Michielin O, Romero P, Monos DS, Zoete V, Gfeller D, Kandalaft LE, Coukos G, Harari A. Sensitive and frequent identification of high avidity neo-epitope specific CD8 + T cells in immunotherapy-naive ovarian cancer. Nat Commun. 2018 Mar 15;9(1):1092. doi: 10.1038/s41467-018-03301-0.

    PubMed 29545564

  • Zhang AW, McPherson A, Milne K, Kroeger DR, Hamilton PT, Miranda A, Funnell T, Little N, de Souza CPE, Laan S, LeDoux S, Cochrane DR, Lim JLP, Yang W, Roth A, Smith MA, Ho J, Tse K, Zeng T, Shlafman I, Mayo MR, Moore R, Failmezger H, Heindl A, Wang YK, Bashashati A, Grewal DS, Brown SD, Lai D, Wan ANC, Nielsen CB, Huebner C, Tessier-Cloutier B, Anglesio MS, Bouchard-Cote A, Yuan Y, Wasserman WW, Gilks CB, Karnezis AN, Aparicio S, McAlpine JN, Huntsman DG, Holt RA, Nelson BH, Shah SP. Interfaces of Malignant and Immunologic Clonal Dynamics in Ovarian Cancer. Cell. 2018 Jun 14;173(7):1755-1769.e22. doi: 10.1016/j.cell.2018.03.073. Epub 2018 May 10.

    PubMed 29754820

  • Mayor P, Starbuck K, Zsiros E. Adoptive cell transfer using autologous tumor infiltrating lymphocytes in gynecologic malignancies. Gynecol Oncol. 2018 Aug;150(2):361-369. doi: 10.1016/j.ygyno.2018.05.024. Epub 2018 May 24.

    PubMed 29803316

  • van Driel WJ, Koole SN, Sikorska K, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, de Hingh IHJT, van der Velden J, Arts HJ, Massuger LFAG, Aalbers AGJ, Verwaal VJ, Kieffer JM, Van de Vijver KK, van Tinteren H, Aaronson NK, Sonke GS. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. N Engl J Med. 2018 Jan 18;378(3):230-240. doi: 10.1056/NEJMoa1708618.

    PubMed 29342393

  • Odunsi K. Immunotherapy in ovarian cancer. Ann Oncol. 2017 Nov 1;28(suppl_8):viii1-viii7. doi: 10.1093/annonc/mdx444.

    PubMed 29232467

  • Tran E, Robbins PF, Rosenberg SA. 'Final common pathway' of human cancer immunotherapy: targeting random somatic mutations. Nat Immunol. 2017 Feb 15;18(3):255-262. doi: 10.1038/ni.3682.

    PubMed 28198830

  • Ovarian Tumor Tissue Analysis (OTTA) Consortium; Goode EL, Block MS, Kalli KR, Vierkant RA, Chen W, Fogarty ZC, Gentry-Maharaj A, Toloczko A, Hein A, Bouligny AL, Jensen A, Osorio A, Hartkopf A, Ryan A, Chudecka-Glaz 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, Lubinski J, Menkiszak J, Alsop J, Lester J, Garcia-Donas J, Nation J, Hung J, Palacios J, Rothstein JH, Kelley JL, de Andrade JM, Robles-Diaz 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, Hogdall E, Candido dos Reis FJ, Steed H, Campbell IG, Gronwald J, Benitez J, Koziak JM, Chang-Claude J, Moysich KB, Kelemen LE, Cook LS, Goodman MT, Garcia MJ, Fasching PA, Kommoss S, Deen S, Kjaer SK, Menon U, Brenton JD, Pharoah PDP, Chenevix-Trench G, Huntsman DG, Winham SJ, Kobel 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.

    PubMed 29049607

  • Delcourt V, Franck J, Leblanc E, Narducci F, Robin YM, Gimeno JP, Quanico J, Wisztorski M, Kobeissy F, Jacques JF, Roucou X, Salzet M, Fournier I. Combined Mass Spectrometry Imaging and Top-down Microproteomics Reveals Evidence of a Hidden Proteome in Ovarian Cancer. EBioMedicine. 2017 Jul;21:55-64. doi: 10.1016/j.ebiom.2017.06.001. Epub 2017 Jun 3.

    PubMed 28629911

  • Murakami R, Matsumura N, Mandai M, Yoshihara K, Tanabe H, Nakai H, Yamanoi K, Abiko K, Yoshioka Y, Hamanishi J, Yamaguchi K, Baba T, Koshiyama M, Enomoto T, Okamoto A, Murphy SK, Mori S, Mikami Y, Minamiguchi S, Konishi I. Establishment of a Novel Histopathological Classification of High-Grade Serous Ovarian Carcinoma Correlated with Prognostically Distinct Gene Expression Subtypes. Am J Pathol. 2016 May;186(5):1103-13. doi: 10.1016/j.ajpath.2015.12.029. Epub 2016 Mar 15.

    PubMed 26993207

  • Blank CU, Haanen JB, Ribas A, Schumacher TN. CANCER IMMUNOLOGY. The "cancer immunogram". Science. 2016 May 6;352(6286):658-60. doi: 10.1126/science.aaf2834. No abstract available.

    PubMed 27151852

  • Santoiemma PP, Powell DJ Jr. Tumor infiltrating lymphocytes in ovarian cancer. Cancer Biol Ther. 2015;16(6):807-20. doi: 10.1080/15384047.2015.1040960. Epub 2015 Apr 20.

    PubMed 25894333

  • Hiraoka N, Ino Y, Yamazaki-Itoh R, Kanai Y, Kosuge T, Shimada K. Intratumoral tertiary lymphoid organ is a favourable prognosticator in patients with pancreatic cancer. Br J Cancer. 2015 May 26;112(11):1782-90. doi: 10.1038/bjc.2015.145. Epub 2015 May 5.

    PubMed 25942397

  • Salgado R, Denkert C, Demaria S, Sirtaine N, Klauschen F, Pruneri G, Wienert S, Van den Eynden G, Baehner FL, Penault-Llorca F, Perez EA, Thompson EA, Symmans WF, Richardson AL, Brock J, Criscitiello C, Bailey H, Ignatiadis M, Floris G, Sparano J, Kos Z, Nielsen T, Rimm DL, Allison KH, Reis-Filho JS, Loibl S, Sotiriou C, Viale G, Badve S, Adams S, Willard-Gallo K, Loi S; International TILs Working Group 2014. The evaluation of tumor-infiltrating lymphocytes (TILs) in breast cancer: recommendations by an International TILs Working Group 2014. Ann Oncol. 2015 Feb;26(2):259-71. doi: 10.1093/annonc/mdu450. Epub 2014 Sep 11.

    PubMed 25214542

  • Galluzzi L, Vacchelli E, Bravo-San Pedro JM, Buque 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, Fucikova J, Gabrilovich DI, Galon J, Garg A, Ghiringhelli F, Giaccone G, Gilboa E, Gnjatic S, Hoos A, Hosmalin A, Jager D, Kalinski P, Karre 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, Sautes-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. doi: 10.18632/oncotarget.2998.

    PubMed 25537519

  • Tangye SG, Ma CS, Brink R, Deenick EK. The good, the bad and the ugly - TFH cells in human health and disease. Nat Rev Immunol. 2013 Jun;13(6):412-26. doi: 10.1038/nri3447. Epub 2013 May 17.

    PubMed 23681096

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample collection in people with Ovarian Cancer Stage IIIC and Fallopian Tube Cancer Stage IIIC, run by Centre Oscar Lambret at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: End of recruiting period). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03922776, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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