Ovarian CancerNCT06304922
BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary
An observational study of Ovarian Cancer, run by Assiut University.
Trial summary
The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2026
- 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
- Adult, Older adult
Study population: Ovarian cancer patients
Who may be able to join
- Age above 18 years,
- Pathologically proven ovarian cancer,epithelial origin.
- BRCA mutant/wild
- Recurrent cases who are eligible to anti-VEGF (Bevacizumab).
- Patients with clinical stages T1-T3c , N0-N1b, M0, and recurrent platinum sensitive cases.
- Patients with good renal and liver functions.
- No other malignancy (double malignancy).
- Performance status 0-2 according to ECOG performance status scale.
Who cannot join
- Performance status 3-4 according to ECOG performance status scale.
- Patients refuse to receive chemotherapy,
- Patients not eligible to receive chemotherapy due to liver or renal impairment.
Trial locations and contacts
No sites are listed yet.
About this study
The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer.
Read the detailed description
Ovarian cancer was the third most common gynecological cancer globally in 2020. Ovarian carcinoma is the most common type of ovarian cancer, comprising over 90% of all ovarian cancer cases.
It is the most lethal gynecologic malignancy in high-income countries.
Approximately, 10-15% of epithelial ovarian cancer (EOC) patients carry germline mutation in BRCA1 or BRCA2. But,the majority of cases are sporadic.
Increased body mass index (BMI) and hormone replacement therapy (HRT) have been proposed as major contributors along with smoking and occupational hazards e.g., asbestos exposure.
Studies have reported that the prevalence of BRCA mutations varies among different epithelial ovarian ca ( EOC) subtypes, with prevalence of 20%-25% reported for the high-grade serous subtype , BRCA mutations were reported in <10% of the endometrioid subtype and with very low frequency in clear cell subtype (6.3%).
The absence of BRCA1/2 function is associated with a cumulative lifetime risk for developing epithelial ovarian cancer of 40% to 50% in patients who are BRCA1-mutation carriers and 20% to 25% in patients who are BRCA2-mutation carriers.
Improved prognosis in terms of progression-free survival (PFS) and overall survival (OS), with higher partial response (PR) and complete response (CR) rates to platinum-containing regimens and longer treatment-free intervals, has been observed in retrospective studies of patients who are BRCA1/2-mutant carriers with ovarian cancer compared with patients who are non.
However, despite a generally favorable response to first-line chemotherapy, the disease frequently recurs. Due to limited therapeutic options, sequential chemotherapy regimens are often used based on platinum sensitivity (determined by the platinum-free interval), residual toxicities, general condition/performance status, and co-morbidities, with suboptimal outcomes and cumulative toxicity. Treatment effectiveness decreases over time, with resistance to platinum drugs precluding diminished survival and quality of life.
Germ-line BRCA mutations are associated with longer survival rates after ovarian cancer diagnosis and generally favorable response to platin-based therapy.
No data available for recurrent cases to assess the response of platinum based chemotherapy in BRCA mutant or wild cases.
- Conditions
- Ovarian Cancer
- Being tested
- Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancerBehavioural
Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate.
percentage of people in the study or treatment group who have a partial response or complete response to the treatment within a certain period of time; wil be correlated with BRCA status.
Measured: 1 year
Progression free survival
the time from starting the study till disease progression or death from any cause
Measured: 1 year
Secondary outcomes (1)
Overall survival and toxicity
the length of time from either the date of diagnosis or start of treatment for cancer ovary are still alive
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Haidra Ahmed Garad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304922
- Sponsor's protocol ID
- BRCA 1/2 in cancer ovary
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang J, Chan WC, Ngai CH, Lok V, Zhang L, Lucero-Prisno DE 3rd, Xu W, Zheng ZJ, Elcarte E, Withers M, Wong MCS, On Behalf Of Ncd Global Health Research Group Of Association Of Pacific Rim Universities Apru. Worldwide Burden, Risk Factors, and Temporal Trends of Ovarian Cancer: A Global Study. Cancers (Basel). 2022 Apr 29;14(9):2230. doi: 10.3390/cancers14092230.
PubMed 35565359Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Manchana T, Phoolcharoen N, Tantbirojn P. BRCA mutation in high grade epithelial ovarian cancers. Gynecol Oncol Rep. 2019 Aug 13;29:102-105. doi: 10.1016/j.gore.2019.07.007. eCollection 2019 Aug.
PubMed 31467961Whelan E, Kalliala I, Semertzidou A, Raglan O, Bowden S, Kechagias K, Markozannes G, Cividini S, McNeish I, Marchesi J, MacIntyre D, Bennett P, Tsilidis K, Kyrgiou M. Risk Factors for Ovarian Cancer: An Umbrella Review of the Literature. Cancers (Basel). 2022 May 30;14(11):2708. doi: 10.3390/cancers14112708.
PubMed 35681688Brown KF, Rumgay H, Dunlop C, Ryan M, Quartly F, Cox A, Deas A, Elliss-Brookes L, Gavin A, Hounsome L, Huws D, Ormiston-Smith N, Shelton J, White C, Parkin DM. The fraction of cancer attributable to modifiable risk factors in England, Wales, Scotland, Northern Ireland, and the United Kingdom in 2015. Br J Cancer. 2018 Apr;118(8):1130-1141. doi: 10.1038/s41416-018-0029-6. Epub 2018 Mar 23.
PubMed 29567982Liu H, Zhang Z, Chen L, Pang J, Wu H, Liang Z. Next-Generation Sequencing Reveals a Very Low Prevalence of Deleterious Mutations of Homologous Recombination Repair Genes and Homologous Recombination Deficiency in Ovarian Clear Cell Carcinoma. Front Oncol. 2022 Jan 12;11:798173. doi: 10.3389/fonc.2021.798173. eCollection 2021.
PubMed 35096598Jazaeri AA. Molecular profiles of hereditary epithelial ovarian cancers and their implications for the biology of this disease. Mol Oncol. 2009 Apr;3(2):151-6. doi: 10.1016/j.molonc.2009.01.001. Epub 2009 Feb 7.
PubMed 19383376Coburn SB, Bray F, Sherman ME, Trabert B. International patterns and trends in ovarian cancer incidence, overall and by histologic subtype. Int J Cancer. 2017 Jun 1;140(11):2451-2460. doi: 10.1002/ijc.30676. Epub 2017 Mar 21.
PubMed 28257597Pujade-Lauraine E, Banerjee S, Pignata S. Management of Platinum-Resistant, Relapsed Epithelial Ovarian Cancer and New Drug Perspectives. J Clin Oncol. 2019 Sep 20;37(27):2437-2448. doi: 10.1200/JCO.19.00194. Epub 2019 Aug 12. No abstract available.
PubMed 31403868Alsop K, Fereday S, Meldrum C, deFazio A, Emmanuel C, George J, Dobrovic A, Birrer MJ, Webb PM, Stewart C, Friedlander M, Fox S, Bowtell D, Mitchell G. BRCA mutation frequency and patterns of treatment response in BRCA mutation-positive women with ovarian cancer: a report from the Australian Ovarian Cancer Study Group. J Clin Oncol. 2012 Jul 20;30(21):2654-63. doi: 10.1200/JCO.2011.39.8545. Epub 2012 Jun 18.
PubMed 22711857Tan DS, Kaye SB. Chemotherapy for Patients with BRCA1 and BRCA2-Mutated Ovarian Cancer: Same or Different? Am Soc Clin Oncol Educ Book. 2015:114-21. doi: 10.14694/EdBook_AM.2015.35.114.
PubMed 25993149
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary
- ClinicalTrials.gov ID
- NCT06304922
- Acronym / sponsor ID
- BRCA 1/2 in cancer ovary
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 12 Mar 2024 (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.
The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer.
Detailed description
Ovarian cancer was the third most common gynecological cancer globally in 2020. Ovarian carcinoma is the most common type of ovarian cancer, comprising over 90% of all ovarian cancer cases.
It is the most lethal gynecologic malignancy in high-income countries.
Approximately, 10-15% of epithelial ovarian cancer (EOC) patients carry germline mutation in BRCA1 or BRCA2. But,the majority of cases are sporadic.
Increased body mass index (BMI) and hormone replacement therapy (HRT) have been proposed as major contributors along with smoking and occupational hazards e.g., asbestos exposure.
Studies have reported that the prevalence of BRCA mutations varies among different epithelial ovarian ca ( EOC) subtypes, with prevalence of 20%-25% reported for the high-grade serous subtype , BRCA mutations were reported in <10% of the endometrioid subtype and with very low frequency in clear cell subtype (6.3%).
The absence of BRCA1/2 function is associated with a cumulative lifetime risk for developing epithelial ovarian cancer of 40% to 50% in patients who are BRCA1-mutation carriers and 20% to 25% in patients who are BRCA2-mutation carriers.
Improved prognosis in terms of progression-free survival (PFS) and overall survival (OS), with higher partial response (PR) and complete response (CR) rates to platinum-containing regimens and longer treatment-free intervals, has been observed in retrospective studies of patients who are BRCA1/2-mutant carriers with ovarian cancer compared with patients who are non.
However, despite a generally favorable response to first-line chemotherapy, the disease frequently recurs. Due to limited therapeutic options, sequential chemotherapy regimens are often used based on platinum sensitivity (determined by the platinum-free interval), residual toxicities, general condition/performance status, and co-morbidities, with suboptimal outcomes and cumulative toxicity. Treatment effectiveness decreases over time, with resistance to platinum drugs precluding diminished survival and quality of life.
Germ-line BRCA mutations are associated with longer survival rates after ovarian cancer diagnosis and generally favorable response to platin-based therapy.
No data available for recurrent cases to assess the response of platinum based chemotherapy in BRCA mutant or wild cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Ovarian cancer patients
Key inclusion criteria (8 listed)
- Age above 18 years,
- Pathologically proven ovarian cancer,epithelial origin.
- BRCA mutant/wild
- Recurrent cases who are eligible to anti-VEGF (Bevacizumab).
- Patients with clinical stages T1-T3c , N0-N1b, M0, and recurrent platinum sensitive cases.
Key exclusion criteria (3 listed)
- Performance status 3-4 according to ECOG performance status scale.
- Patients refuse to receive chemotherapy,
- Patients not eligible to receive chemotherapy due to liver or renal impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancerAssess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer | Behavioural | – |
Primary outcome
Objective response rate.
Time frame: 1 year
percentage of people in the study or treatment group who have a partial response or complete response to the treatment within a certain period of time; wil be correlated with BRCA status.
Progression free survival
Time frame: 1 year
the time from starting the study till disease progression or death from any cause
1 secondary outcome
Overall survival and toxicity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 35565359Huang J, Chan WC, Ngai CH, Lok V, Zhang L, Lucero-Prisno DE 3rd, Xu W, Zheng ZJ, Elcarte E, Withers M, Wong MCS, On Behalf Of Ncd Global Health Research Group Of Association Of Pacific Rim Universities Apru. Worldwide Burden, Risk Factors, and Temporal Trends of Ovarian Cancer: A Global Study. Cancers (Basel). 2022 Apr 29;14(9):2230. doi: 10.3390/cancers14092230.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 31467961Manchana T, Phoolcharoen N, Tantbirojn P. BRCA mutation in high grade epithelial ovarian cancers. Gynecol Oncol Rep. 2019 Aug 13;29:102-105. doi: 10.1016/j.gore.2019.07.007. eCollection 2019 Aug.
- Background: PubMed 35681688Whelan E, Kalliala I, Semertzidou A, Raglan O, Bowden S, Kechagias K, Markozannes G, Cividini S, McNeish I, Marchesi J, MacIntyre D, Bennett P, Tsilidis K, Kyrgiou M. Risk Factors for Ovarian Cancer: An Umbrella Review of the Literature. Cancers (Basel). 2022 May 30;14(11):2708. doi: 10.3390/cancers14112708.
- Background: PubMed 29567982Brown KF, Rumgay H, Dunlop C, Ryan M, Quartly F, Cox A, Deas A, Elliss-Brookes L, Gavin A, Hounsome L, Huws D, Ormiston-Smith N, Shelton J, White C, Parkin DM. The fraction of cancer attributable to modifiable risk factors in England, Wales, Scotland, Northern Ireland, and the United Kingdom in 2015. Br J Cancer. 2018 Apr;118(8):1130-1141. doi: 10.1038/s41416-018-0029-6. Epub 2018 Mar 23.
- Background: PubMed 35096598Liu H, Zhang Z, Chen L, Pang J, Wu H, Liang Z. Next-Generation Sequencing Reveals a Very Low Prevalence of Deleterious Mutations of Homologous Recombination Repair Genes and Homologous Recombination Deficiency in Ovarian Clear Cell Carcinoma. Front Oncol. 2022 Jan 12;11:798173. doi: 10.3389/fonc.2021.798173. eCollection 2021.
- Background: PubMed 19383376Jazaeri AA. Molecular profiles of hereditary epithelial ovarian cancers and their implications for the biology of this disease. Mol Oncol. 2009 Apr;3(2):151-6. doi: 10.1016/j.molonc.2009.01.001. Epub 2009 Feb 7.
- Background: PubMed 28257597Coburn SB, Bray F, Sherman ME, Trabert B. International patterns and trends in ovarian cancer incidence, overall and by histologic subtype. Int J Cancer. 2017 Jun 1;140(11):2451-2460. doi: 10.1002/ijc.30676. Epub 2017 Mar 21.
- Background: PubMed 31403868Pujade-Lauraine E, Banerjee S, Pignata S. Management of Platinum-Resistant, Relapsed Epithelial Ovarian Cancer and New Drug Perspectives. J Clin Oncol. 2019 Sep 20;37(27):2437-2448. doi: 10.1200/JCO.19.00194. Epub 2019 Aug 12. No abstract available.
- Background: PubMed 22711857Alsop K, Fereday S, Meldrum C, deFazio A, Emmanuel C, George J, Dobrovic A, Birrer MJ, Webb PM, Stewart C, Friedlander M, Fox S, Bowtell D, Mitchell G. BRCA mutation frequency and patterns of treatment response in BRCA mutation-positive women with ovarian cancer: a report from the Australian Ovarian Cancer Study Group. J Clin Oncol. 2012 Jul 20;30(21):2654-63. doi: 10.1200/JCO.2011.39.8545. Epub 2012 Jun 18.
- Background: PubMed 25993149Tan DS, Kaye SB. Chemotherapy for Patients with BRCA1 and BRCA2-Mutated Ovarian Cancer: Same or Different? Am Soc Clin Oncol Educ Book. 2015:114-21. doi: 10.14694/EdBook_AM.2015.35.114.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Assiut University.
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nesreen Haidra Garad, MD/PhD (00966-547-210-285, Nesreengarad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06304922, which also lists 11 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 12 Mar 2024.