- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03877796
Clinical Pre-screening Protocol for Ovarian Cancer
January 30, 2024 updated by: Allarity Therapeutics
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
60
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: Europe: Rebecca Kristeleit
- Email: Rebecca.Kristeleit@gstt.nhs.uk
Study Contact Backup
- Name: US: Kathleen Moore
- Phone Number: +1 405-271-8707
- Email: KathleenMoore@ouhealth.com
Study Locations
-
-
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London, United Kingdom
- Recruiting
- Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital
-
Contact:
- Rebecca Kristeleit, MD
-
Contact:
- Mai Worthington
-
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Scotland
-
Glasgow, Scotland, United Kingdom, G12 0YN
- Recruiting
- Beatson West of Scotland Cancer Centre
-
Principal Investigator:
- Ros Glasspool, MD
-
Contact:
- Lauren Mcnamara
- Email: lauren.mcnamara@ggc.scot.nhs.uk
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-
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Completed
- Dana-Farber Cancer Institute
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- OU Health Stephenson Cancer Center
-
Principal Investigator:
- Kathleen Moore, MD
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Contact:
- Christine Pappaterra, RN
- Phone Number: 405-271-8707
- Email: Christine-Pappaterra@ouhsc.edu
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Washington
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Seattle, Washington, United States, 98122
- Recruiting
- Swedish Center for Research and Innovation
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Contact:
- Karina Sills
- Phone Number: 206-386-2227
- Email: karina.sills@swedish.org
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Principal Investigator:
- Fernanda Baptista Musa, MD
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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 and older (Adult, Older Adult)
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
Description
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
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
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ovarian cancer patients
with formalin-fixed paraffin-embedded (FFPE) tumor tissue available
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
April 11, 2019
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
March 14, 2019
First Submitted That Met QC Criteria
March 14, 2019
First Posted (Actual)
March 18, 2019
Study Record Updates
Last Update Posted (Actual)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
March 1, 2023
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
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- 2X-1000
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
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.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
Clinical Trials on Drug Response Predictor® (DRP)
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Allarity TherapeuticsAmarex Clinical Research; Alcedis GmbHRecruitingAdvanced Ovarian CancerUnited Kingdom, United States
-
German Cancer Research CenterUniversity Hospital HeidelbergCompletedHematologic Diseases | TreatmentGermany
-
Canadian Forces Health Services Centre OttawaSuspended
-
University of PisaRecruiting
-
Centre Jean PerrinCompletedBreast Cancer Patients | Therapy Related TumorFrance
-
Hospital Universitari Vall d'Hebron Research InstituteB.Braun Surgical SACompleted
-
Foundation for Innovative New Diagnostics, SwitzerlandMinistry of Health, Malaysia; Hospital Sultanah Bahiyah; Malaysian AIDS CouncilRecruiting
-
Gilead SciencesCompletedHepatitis C Virus InfectionNew Zealand
-
Cook Research IncorporatedCompleted