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Effects of Cytotoxic Chemotherapy and PARP Inhibition on the Genomic Contexture of Ovarian Cancer

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: NCT04752865
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Hellenic Cooperative Oncology Group

Study Description
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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.

Condition or disease
Ovarian Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Effects of Cytotoxic Chemotherapy and PARP Inhibition on the Genomic Contexture of Ovarian Cancer
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : December 29, 2022
Estimated Study Completion Date : December 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. assesment of genomic characteristics of ovarian tumors at the diagnosis [ Time Frame: 4 years ]
  2. assesment of genomic characteristics of ovarian tumors after treatment with neoadjuvant platinum-based chemotherapy [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • ovarian cancer eligible for neoadjuvant chemotherapy

Exclusion Criteria:

-

Contacts and Locations
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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): NCT04752865


Contacts
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Contact: Adamantia Nikolaidi, MD 00302106912520 ext 12 hecogoff@otenet.gr
Contact: Maria Moschoni 00302106912520 ext 12 m_moschoni@hecog.ondsl.gr

Locations
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Greece
Adamantia Nikolaidi Recruiting
Athens, Greece, 11524
Contact: Maria Moschoni    00302106912520 ext 12    hecogoff@otenet.gr   
Sponsors and Collaborators
Hellenic Cooperative Oncology Group
Investigators
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Study Chair: Adamantia Nikolaidi HECOG
More Information
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Responsible Party: Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT04752865    
Other Study ID Numbers: TR_NACT_OV/17
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type