Fallopian Tube CancerHALONCT04991051
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
An observational study of Fallopian Tube Cancer, run by AstraZeneca at 24 sites in 6 countries.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer
- How many people
- 605 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 2 May 2021to 15 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
Russia18 sites
Research Site
Arkhangelsk
Research Site
Balashikha, Moscow Oblast
Research Site
Belgorod
Research Site
Chelyabinsk
Research Site
Irkutsk
Research Site
Istra Settlement, Moscow Oblast
Research Site
Kolomna, Moscow Oblast
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Tomsk
Research Site
Tula
Research Site
Tyumen
Research Site
Ufa
Research Site
Yaroslavl
Research Site
Yuzhno-Sakhalinsk
About this study
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.
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
Read the 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.
- Conditions
- Fallopian Tube Cancer
- Keywords
- Cancer, HRD-testing, ovarian
- Medical subject headings
- Fallopian Tube Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall percentage of patients diagnosed with positive HRD status
At baseline of this study
Measured: Baseline
Secondary outcomes (4)
Region- and country-specific percentages of patients with positive HRD status
At baseline of this study
Measured: Baseline
Overall, region- and country-specific percentages of patients with tBRCA1m/tBRCA2m within each geographical region
At baseline of this study
Measured: Baseline
Overall, region- and country-specific percentages of patients with GIS-positive status within each geographical region
At baseline of this study
Measured: Baseline
Association of HRD-positive status and tBRCA1m/tBRCA2m
At baseline of this study
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start2 May 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991051
- Sponsor's protocol ID
- D0818R00007
- Acronym
- HALO
- Status last verified
- Feb 2024
- First submitted
- 8 Jul 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
Publications
Shash E, Vardar MA, Taskiran C, Boujassoum S, Riromar J, Aboutaleb A, Sadek F, Samy E, Bahaj W. Homologous recombination deficiency in newly diagnosed advanced ovarian cancer across nine Middle East countries: prevalence, real-world testing pathways, and treatment implications. BMC Cancer. 2026 Feb 4;26(1):296. doi: 10.1186/s12885-025-15537-3.
PubMed 41639797Liou WS, Chao A, Sheu BC, Yeh LS, Wu CH. Prevalence of homologous recombination deficiency in ovarian, primary peritoneal, and/or fallopian tube cancer: results from HALO-Taiwan subset. J Gynecol Oncol. 2026 May;37(3):e55. doi: 10.3802/jgo.2026.37.e55. Epub 2025 Dec 29.
PubMed 41575336Khokhlova S, Alnaqqash MA, Bahaj W, Bujassoum S, Lee J, Mokhtar M, Tyulyandina A, Vargas Malaga CL, Wu CH. Prevalence of homologous recombination deficiency among women with newly diagnosed ovarian, primary peritoneal, and/or fallopian tube cancer: the international HALO study. Int J Gynecol Cancer. 2025 Jul;35(7):101645. doi: 10.1016/j.ijgc.2025.101645. Epub 2025 Jan 17.
PubMed 40064569
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04991051
- Acronym / sponsor ID
- HALO / D0818R00007
- Conditions
- Fallopian Tube Cancer
- Keywords
- Cancer, HRD-testing, ovarian
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 2 May 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The overall percentage of patients diagnosed with positive HRD status
Time frame: Baseline
At baseline of this study
4 secondary outcomes
Region- and country-specific percentages of patients with positive HRD status
Time frame: Baseline
Overall, region- and country-specific percentages of patients with tBRCA1m/tBRCA2m within each geographical region
Time frame: Baseline
Overall, region- and country-specific percentages of patients with GIS-positive status within each geographical region
Time frame: Baseline
Association of HRD-positive status and tBRCA1m/tBRCA2m
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 41639797Shash E, Vardar MA, Taskiran C, Boujassoum S, Riromar J, Aboutaleb A, Sadek F, Samy E, Bahaj W. Homologous recombination deficiency in newly diagnosed advanced ovarian cancer across nine Middle East countries: prevalence, real-world testing pathways, and treatment implications. BMC Cancer. 2026 Feb 4;26(1):296. doi: 10.1186/s12885-025-15537-3.
- Derived from this study: PubMed 41575336Liou WS, Chao A, Sheu BC, Yeh LS, Wu CH. Prevalence of homologous recombination deficiency in ovarian, primary peritoneal, and/or fallopian tube cancer: results from HALO-Taiwan subset. J Gynecol Oncol. 2026 May;37(3):e55. doi: 10.3802/jgo.2026.37.e55. Epub 2025 Dec 29.
- Derived from this study: PubMed 40064569Khokhlova S, Alnaqqash MA, Bahaj W, Bujassoum S, Lee J, Mokhtar M, Tyulyandina A, Vargas Malaga CL, Wu CH. Prevalence of homologous recombination deficiency among women with newly diagnosed ovarian, primary peritoneal, and/or fallopian tube cancer: the international HALO study. Int J Gynecol Cancer. 2025 Jul;35(7):101645. doi: 10.1016/j.ijgc.2025.101645. Epub 2025 Jan 17.
- CSR SynopsisLink provided by the sponsor.
Related trials for Fallopian Tube Cancer
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fallopian Tube Cancer, run by AstraZeneca at 24 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Russia, Saudi Arabia, Kuwait, Oman, Qatar and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall percentage of patients diagnosed with positive HRD status (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04991051, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.