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Study to Determine the Prevalence of Homologous Recombination Deficiency Among Women With Newly Diagnosed, High-grade, Serous or Endometrioid Ovarian, Primary Peritoneal, and/or Fallopian Tube Cancer (HALO)

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ClinicalTrials.gov Identifier: NCT04991051
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

To maximise the accessibility and benefit of PARP inhibitors to eligible patients, it is essential to know the prevalence of HRD in women with advanced high-grade serous or endometrioid ovarian cancer. Presently, the prevalence data for HRD are available from selected geographies only and range from 31% to 50%. Furthermore, the risk factors associated with HRD and clinical characteristics of patients with HRD need exploration for region-specific differences. In the present study, we will estimate the region- and country-specific prevalence of HRD in women with stage III or IV high-grade serous or endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer and associated risk factors with clinical characteristics in Asia-Pacific countries, Latin America, Africa, Russia, Australia, and Middle East countries.

The findings of the study will help the oncologists in optimal patient selection and clinical decision-making for the first-line maintenance of patients with HGSOC


Condition or disease
Fallopian Tube Cancer

Detailed Description:

This cross-sectional, noninterventional, multicentre, epidemiological, observational study is designed to determine the prevalence of HRD in patients with newly diagnosed high-grade serous or endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer. The study will also determine the prevalence of tBRCA1m/tBRCA2m, genomic instability, and identify the associated risk factors in several countries across broad geographic regions. The patients with newly diagnosed high-grade (stage III or IV of Federation of Gynecology and Obstetrics [FIGO] classification 2014, Prat J, 2015) ovarian cancer, having the availability of formalin-fixed paraffin-embedded (FFPE) archival tumour tissue block(s) collected within past 120 days will be screened to enrol a minimum of 405 women after obtaining written informed consent and eligibility assessment. The FFPE tumour tissue block(s) collected as part of routine clinical care at public or private ovarian cancer management and or diagnostic facilities in the selected countries will be sent for testing at Myriad Genetics laboratories Inc.

at Salt Lake City, United States of America (USA) through Myriad's local logistics network.

This study will have a single visit.

The study centres and the respective investigators will be selected through a site-level feasibility process after assessing the following:

  • availability of the average number patients with newly diagnosed stage III and IV serous or endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer.
  • completeness of patient medical records pertaining to diagnostics and having the facility, capacity, and competence of collecting and archiving FFPE tumour tissue block(s).

Assessment and selection of study centres by the study sponsor AstraZeneca (AZ) will be an ongoing process during the entire course of the study until completion of recruitment.

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Study Type : Observational
Estimated Enrollment : 405 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: HRDx-Ovarian. A Cross-sectional, Noninterventional, Multicentre Study to Determine the Prevalence of Homologous Recombination Deficiency Among Women With Newly Diagnosed, High-grade, Serous or Endometrioid Ovarian, Primary Peritoneal, and/or Fallopian Tube Cancer.
Actual Study Start Date : May 2, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022





Primary Outcome Measures :
  1. The overall percentage of patients diagnosed with positive HRD status [ Time Frame: Baseline ]
    At baseline of this study


Secondary Outcome Measures :
  1. Region- and country-specific percentages of patients with positive HRD status [ Time Frame: Baseline ]
    At baseline of this study

  2. Overall, region- and country-specific percentages of patients with tBRCA1m/tBRCA2m within each geographical region [ Time Frame: Baseline ]
    At baseline of this study

  3. Overall, region- and country-specific percentages of patients with GIS-positive status within each geographical region [ Time Frame: Baseline ]
    At baseline of this study

  4. Association of HRD-positive status and tBRCA1m/tBRCA2m [ Time Frame: Baseline ]
    At baseline of this study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with high-grade (stage III or IV of FIGO classification 2014) ovarian cancer will be eligible for inclusion into the study if they meet all of the inclusion criteria and none of the exclusion criteria.
Criteria

Inclusion Criteria:

  • Patients ≥18 years of age or adults according to age of majority as defined by the local regulations;
  • Willing and able to provide written informed consent for participation in the study;
  • Patients with histologically confirmed new diagnosis (within past 120 days of enrolment) of high-grade (stage III or IV of FIGO classification 2014) serous or endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer;
  • Patients having availability of histopathology report and FFPE archival tumour tissue block(s) collected within past 120 days of enrolment.

Exclusion Criteria:

  • Patients with mucinous, clear-cell, undifferentiated carcinoma or malignant Brenner's tumour;
  • Patients diagnosed with any severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results, and those in the judgment of the investigator are not appropriate for enrolment in this study

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): NCT04991051


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Russian Federation
Research Site Active, not recruiting
Arkhangelsk, Russian Federation
Research Site Active, not recruiting
Balashikha Urban District, Russian Federation
Research Site Active, not recruiting
Belgorod, Russian Federation
Research Site Active, not recruiting
Chelyabisk, Russian Federation
Research Site Active, not recruiting
Irkutsk, Russian Federation
Research Site Active, not recruiting
Istra Settlement, Russian Federation
Research Site Active, not recruiting
Kolomna, Russian Federation
Research Site Active, not recruiting
Krasnoyarsk, Russian Federation
Research Site Active, not recruiting
Moscow, Russian Federation
Research Site Active, not recruiting
Nizhniy Novgorod, Russian Federation
Research Site Active, not recruiting
Otradnoye Settlement, Russian Federation
Research Site Active, not recruiting
Rostov-on-Don, Russian Federation
Research Site Active, not recruiting
Saint Petersburg, Russian Federation
Research Site Active, not recruiting
Tomsk, Russian Federation
Research Site Active, not recruiting
Tula, Russian Federation
Research Site Active, not recruiting
Tyumen, Russian Federation
Research Site Active, not recruiting
Ufa, Russian Federation
Research Site Active, not recruiting
Voronezh, Russian Federation
Research Site Active, not recruiting
Yaroslavl, Russian Federation
Research Site Active, not recruiting
Yuzhno-Sakhalinsk, Russian Federation
Singapore
Research Site Recruiting
Singapore, Singapore
Turkey
Research Site Recruiting
Adana, Turkey
Research Site Recruiting
Ankara, Turkey
Research Site Recruiting
Istanbul, Turkey
Research Site Recruiting
Izmir, Turkey
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04991051    
Other Study ID Numbers: D0818R00007
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Keywords provided by AstraZeneca:
Cancer, HRD-testing, ovarian
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases