Effects of Cytotoxic Chemotherapy and PARP Inhibition on the Genomic Contexture of Ovarian Cancer
1 other identifier
observational
50
1 country
1
Brief Summary
EFFECTS OF CYTOTOXIC CHEMOTHERAPY AND PARP INHIBITION ON THE GENOMIC CONTEXTURE OF OVARIAN CANCER: TR\_NACT\_OV/17 In order to approach the above open questions, ultimately aiming in understanding the effects of cancer drugs on tumor biology and hence in selecting the proper drugs for the patients in the context of Precision Medicine, the objective of this study is to study the genomic characteristics of ovarian tumors before and after treatment with classic neoadjuvant chemotherapy (NACT) and with the more recently approved PARP inhibitor olaparib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2018
CompletedFirst Submitted
Initial submission to the registry
December 17, 2020
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedMarch 1, 2023
August 1, 2022
5.8 years
December 17, 2020
February 28, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
assesment of genomic characteristics of ovarian tumors at the diagnosis
4 years
assesment of genomic characteristics of ovarian tumors after treatment with neoadjuvant platinum-based chemotherapy
4 years
Eligibility Criteria
women with ovarian cancer eligible for neoadjuvant chemotherapy. The investigators examined changes in tissue molecular profile. The investigators examine tissue molecular profile at diagnosis and after the end of neoadjuvant chemotherapy
You may qualify if:
- ovarian cancer eligible for neoadjuvant chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adamantia Nikolaidi
Athens, 11524, Greece
Biospecimen
FFPE tissues will be histologically reviewed for tumor presence and evaluated for tumor cell content (TCC%) and adequacy for genotyping, tumor lymphocytic infiltrates (TILs) and further morphologic features (presence of intraepithelial lymphocytes, micro- and macro-necrosis, hemorrhagic infiltrates, specific and heterogeneous morphologic patterns) that will be recorded in detail.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Adamantia Nikolaidi
HECOG
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2020
First Posted
February 12, 2021
Study Start
February 9, 2018
Primary Completion
December 1, 2023
Study Completion
June 1, 2024
Last Updated
March 1, 2023
Record last verified: 2022-08