BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary

NCT06304922 | Not Yet Recruiting

• 1 other identifier: BRCA 1/2 in cancer ovary
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• Progression free survival

  the time from starting the study till disease progression or death from any cause

  1 year

Secondary Outcomes (1)

• Overall survival and toxicity

  2 years

Interventions

Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer BEHAVIORAL

Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ovarian cancer patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (11)

• 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.

  PMID: 35565359 BACKGROUND

• Bray 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.

  PMID: 30207593 BACKGROUND

• Manchana 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.

  PMID: 31467961 BACKGROUND

• Whelan 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.

  PMID: 35681688 BACKGROUND

• Brown 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.

  PMID: 29567982 BACKGROUND

• Liu 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.

  PMID: 35096598 BACKGROUND

• Jazaeri 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.

  PMID: 19383376 BACKGROUND

• Coburn 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.

  PMID: 28257597 BACKGROUND

• Pujade-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.

  PMID: 31403868 BACKGROUND

• Alsop 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.

  PMID: 22711857 BACKGROUND

• Tan 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.

  PMID: 25993149 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Nesreen Haidra Garad, MD/PhD

CONTACT

00966-547-210-285; Nesreengarad@gmail.com

Hanan Gamal Mustafa, MD/PhD

CONTACT

0020-100408-2002; mostafahanan36@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03