- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04752865
Effects of Cytotoxic Chemotherapy and PARP Inhibition on the Genomic Contexture of Ovarian Cancer
February 28, 2023 updated by: Hellenic Cooperative Oncology Group
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adamantia Nikolaidi, MD
- Phone Number: 12 00302106912520
- Email: hecogoff@otenet.gr
Study Contact Backup
- Name: Maria Moschoni
- Phone Number: 12 00302106912520
- Email: m_moschoni@hecog.ondsl.gr
Study Locations
-
-
-
Athens, Greece, 11524
- Recruiting
- Adamantia Nikolaidi
-
Contact:
- Maria Moschoni
- Phone Number: 12 00302106912520
- Email: hecogoff@otenet.gr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
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
Description
Inclusion Criteria:
- ovarian cancer eligible for neoadjuvant chemotherapy
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
assesment of genomic characteristics of ovarian tumors at the diagnosis
Time Frame: 4 years
|
4 years
|
assesment of genomic characteristics of ovarian tumors after treatment with neoadjuvant platinum-based chemotherapy
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Adamantia Nikolaidi, HeCOG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2018
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
December 17, 2020
First Submitted That Met QC Criteria
February 11, 2021
First Posted (Actual)
February 12, 2021
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 28, 2023
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- TR_NACT_OV/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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