The Immune Landscape of Epithelial Ovarian Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05984875

Studienbeginn:
Dezember 2022

Letztes Update:
09.08.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Oncology Institute of Southern Switzerland

Collaborator:
Institute of Oncology Research

Kontakt

Ilaria Colombo, MD
Kontakt:
Phone: +41764528823
E-Mail: ilaria.colombo@eoc.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Oncology Institute of Southern Switzerland
6500 Bellinzona
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Ilaria Colombo, MD
Phone: +41764528823
E-Mail: ilaria.colombo@eoc.ch» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

This is a single center prospective observational study to characterize the immune landscape

of newly diagnosed epithelial ovarian cancer (OC).

Patients with newly diagnosed epithelial OC will be enrolled in 4 different cohorts: A) Newly

diagnosed high grade serous or endometroid OC undergoing primary debulking surgery; B) Newly

diagnosed high grade serous or endometroid OC undergoing neoadjuvant chemotherapy (NACT)

followed by interval debulking surgery; C) Rare subtypes of epithelial OC (low grade serous,

low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking

surgery; D) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear

cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. A

cohort of women undergoing adnexectomy for benign pathology will be enrolled (cohort E) for

comparative analysis.

Enrolled patients will be asked to provide the following biological samples at specified time

points: archival and fresh tumor tissue, peripheral blood samples, rectal and vaginal swabs,

ascites (when present).

The main aim of the study is to characterize the immune landscape of epithelial OC in tumor

tissue and peripheral blood and correlate the presence of myeloid-derived suppressive cells

(MDSCs) and other immune infiltrates and of the systemic immune response with progression

free interval (PFI) in epithelial OC.

Ein-/Ausschlusskriterien

Inclusion criteria cohort A-D:

- Suspicious diagnosis of epithelial ovarian cancer (subsequent histologically

confirmation required)

- Plan to undergo a surgical procedure for the management of epithelial ovarian cancer

or recurrent ovarian cancer previously treated with conventional treatment and

involved in the trial as group A-D

- ≥18 years old

- ECOG Performance Status ≤ 2

- Written informed consent

Inclusion criteria cohort E:

- Indication for adnexectomy for a benign gynecological condition

- ≥18 years old

- ECOG Performance Status ≤ 2

- Written informed consent

Exclusion criteria cohort A-E:

- Other active concomitant neoplasms that might confound the results of the planned

analysis.

- Ongoing active autoimmune disease requiring treatment or condition of immune

deficiency

- Ongoing chronic treatment with steroids or other immune suppressive agents at the time

of study entry

Studien-Rationale

Primary outcome:

1. Characterization of the immune cells infiltrate (Time Frame - At the time of diagnosis in the tumor tissue and on blood. For patients receiving chemotherapy, assessment on blood after cycle 3 and 6):
Expression of multiple immune cell markers will be assessed in samples from different subtypes of epithelial ovarian cancer by flow cytometric analysis. Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated.

Secondary outcome:

1. To define the prognostic value of the immune cells infiltrate (Time Frame - From diagnosis until disease progression or study termination, whichever will occur first):
The prognostic value of the immune cell populations identified by flow cytometry will be evaluated by calculating the correlation coefficient between the percentage of the immune cell population and the progression-free interval.

Studien-Arme

A
Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery
B
Newly diagnosed high grade serous or endometroid OC undergoing NACT followed by interval debulking surgery. This cohort also includes patients that will not be deemed suitable for interval debulking surgery following NACT
C
Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery
D
Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. This cohort also includes patients with the selected histological subtypes that will not be deemed suitable to interval debulking surgery following NACT
E
Women undergoing adnexectomy for benign pathology

Geprüfte Regime

Collection of tumor samples, blood and vaginal and rectal swabs:
The following biological samples will be collected at different time points, according to the specified cohort and after signing the inform consent form: tumor tissue (fresh and archival) or normal tissue (cohort E), ascites (when present), peripheral blood, rectal swab, vaginal swab.

Quelle: ClinicalTrials.gov

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