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Clinical Pre-screening Protocol for 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: NCT03877796
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Amarex Clinical Research
Information provided by (Responsible Party):
Oncology Venture

Brief Summary:
The pre-screening study is established to pre-screen tumor samples from ovarian cancer patients to identify if they, at a later stage of their disease, will benefit from treatment with any investigational cancer drugs available to Oncology Venture, when these drugs are approved for future clinical studies by local authorities.

Condition or disease Intervention/treatment
Ovarian Cancer Device: Drug Response Predictor® (DRP)

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Other
Official Title: Clinical Pre-screening Protocol for Ovarian Cancer
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort Intervention/treatment
Ovarian cancer patients
with formalin-fixed paraffin-embedded (FFPE) tumor tissue available
Device: Drug Response Predictor® (DRP)
A DRP is an assay that based on samples from a tumor can predict whether the tumor will respond to a specific drug or not.




Primary Outcome Measures :
  1. Identification of ovarian cancer patients with high likelihood of being sensitive to investigational cancer drug [ Time Frame: up to 2 years ]
    based on FFPE ovarian cancer tissue


Secondary Outcome Measures :
  1. Retrospective analysis of whether or not the DRP method can predict and confirm the obtained sensitivity to the prior drugs used in the treatment of ovarian cancer [ Time Frame: up to 2 years ]

Biospecimen Retention:   Samples With DNA
Samples with archival ovarian cancer tumor tissue is collected for measurement using mRNA or microRNA.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be identified at their already planned treatment and or at control visits at the oncology department
Criteria

Inclusion Criteria:

  • Patients with histological confirmed epithelia ovarian cancer
  • Relapse after 2 or more chemotherapies for ovarian cancer
  • FFPE tumor tissue available

Exclusion Criteria:

  • Other primary malignancy within the last 5 years prior to enrolment

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): NCT03877796


Contacts
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Contact: Christin Whalen, MD +617-582-7738 christin_whalen@DFCI.HARVARD.EDU

Locations
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United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Oncology Venture
Amarex Clinical Research

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Responsible Party: Oncology Venture
ClinicalTrials.gov Identifier: NCT03877796     History of Changes
Other Study ID Numbers: 2X-1000
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a 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
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma