UMIN-CTR Clinical Trial

Basic information
Public title	Characterizing the cross-sectional approach to investigate the prevalence of tissue BRCA1/2 mutations in newly diagnosed advanced ovarian cancer patients
Acronym	Characterizing the cross-sectional approach to investigate the prevalence of tissue BRCA1/2 mutations in newly diagnosed advanced ovarian cancer patients(CHRISTELLE Study)
Scientific Title	Characterizing the cross-sectional approach to investigate the prevalence of tissue BRCA1/2 mutations in newly diagnosed advanced ovarian cancer patients
Scientific Title:Acronym	Characterizing the cross-sectional approach to investigate the prevalence of tissue BRCA1/2 mutations in newly diagnosed advanced ovarian cancer patients(CHRISTELLE Study)
Region	Japan

Condition
Condition	Patients with newly diagnosed (at the first diagnosis of) FIGO stage III - IV ovarian cancer (OC)
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the prevalence of tissue BRCA mutation (tBRCAm) in the subjects
Basic objectives2	Others
Basic objectives -Others	<Secondary objectives> 1.To investigate the prevalence of germline BRCA mutation (gBRCAm) in the subjects 2.To investigate the prevalence of somatic BRCA mutation (sBRCAm) in the subjects 3.To investigate the ratio of sBRCAm out of tBRCAm <Exploratory Objectives> 1.To assess tBRCA variant description 2.To assess prevalence of HRD (homologous recombination deficiency) 3.To evaluate prevalence of tBRCAm and HRD score in each subgroup as below; Age, Menopausal status, Cancer type, Histological classification (central pathologist reviewing), FIGO stage, History of cancer, Family history of cancer, History of smoking
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	For BRCA1 and BRCA2 mutations detected by Myriad myChoice HRD, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious / variant of uncertain significance (VUS) / favor polymorphism / no mutation detected
Key secondary outcomes	<Secondary Endpoints> 1.For BRCA1 and BRCA2 mutations detected by BRACAnalysis, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious / variant of uncertain significance (VUS) / favor polymorphism / no mutation detected 2.For BRCA1 and BRCA2 mutations detected by BRACAnalysis and Myriad myChoice HRD, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious 3.The rate of sBRCAm out of tBRCAm <Exploratory Endpoints> 1.BRCA1 and BRCA2 variants detected by Myriad myChoice HRD (location and type of mutation) 2.HRD score; positive / negative 3.BRCA1/2 and HRD score detected by Myriad myChoice HRD will be classified as follows; Age, Menopausal status, Cancer type, Histological classification (central pathologist reviewing), FIGO stage, medical history, Family history of cancer, History of smoking

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1.Aged 20 years or older of Japanese women at the time of consent (the age of death, in case of dead patient) 2.Newly diagnosed as advanced OC (FIGO stage III - IV) with epithelial ovarian cancer, primary peritoneal cancer or fallopian-tube cancer [or a combination thereof] after January 1, 2019 3.Patients who have archived formalin-fixed paraffin-embedded (FFPE) samples of primary or peritoneal metastatic tumor collected after January 1, 2019 4.Patients who have performed BRACAnalysis or who are going to be diagnosed by it 5.Patients who give their written informed consent to participate in this study (However, the cases of death should be handled in accordance with the instructions of the Ethical Review Board of each site.)
Key exclusion criteria	1.Patients who are not recommended enrolling this study decided by study investigator
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Masahisa Middle name Last name Jinushi
Organization	AstraZeneca K.K.
Division name	Medical, Oncology
Zip code	530-0011
Address	Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka 530-0011
TEL	06-7711-3560
Email	Masahisa.jinushi@astrazeneca.com

Public contact
Name of contact person	1st name Mika Middle name Last name Kanno
Organization	Linical Co.,Ltd.
Division name	Contract Medical Affairs Unit, Clinical Trial Operations
Zip code	105-0021
Address	1-9-2 Higashi-shimbashi, Minato-ku, Tokyo, 105-0021, Japan
TEL	03-6215-8005
Homepage URL
Email	kanno-mika@linical.co.jp

Sponsor
Institute	AstraZeneca K.K.
Institute
Department

Funding Source
Organization	AstraZeneca K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Linical Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

Secondary IDs
Secondary IDs	YES
Study ID_1	D0817R00018
Org. issuing International ID_1	AstraZeneca K.K.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

産業医科大学病院（福岡県）、国立大学法人 熊本大学病院（熊本県）、国立大学法人山形大学医学部附属病院（山形県）、国立大学法人新潟大学医歯学総合病院（新潟県）、国立大学法人 筑波大学附属病院（茨城県）、国立大学法人愛媛大学医学部附属病院（愛媛県）、独立行政法人 労働者健康安全機構 関西労災病院（兵庫県）、札幌医科大学附属病院（北海道）、奈良県立医科大学附属病院（奈良県）、独立行政法人国立病院機構 四国がんセンター（愛媛県）、国立大学法人東京大学医学部附属病院（東京都）、国立大学法人 岐阜大学医学部附属病院（岐阜県）、慶應義塾大学病院（東京都）、日本赤十字社 武蔵野赤十字病院（東京都）、福井大学医学部附属病院（福井県）、国立大学法人島根大学医学部附属病院（島根県）、地方独立行政法人神戸市民病院機構　神戸市立医療センター中央市民病院（兵庫県）、国立大学法人東北大学 東北大学病院（宮城県）、東京慈恵会医科大学附属病院（東京都）、公立大学法人福島県立医科大学附属病院（福島県）

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 27 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Unpublished

Result
URL related to results and publications	Unpublished
Number of participants that the trial has enrolled	206
Results	This study was conducted in 20 study sites in Japan and included patients with newly diagnosed OC of FIGO stage III and IV.
Results date posted	2021 Year 12 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Two patients (1.0%) had died in the Per protocol analysis set (PPS: 99.0%). The mean (SD) age of the PPS at diagnosis was 59.4 (10.9) years, and 151 patients (73.7%) were post-menopausal. The patients were diagnosed OC of FIGO stage III in 137 patients (66.8%) and IV in 68 patients (33.2%). OC types were as follows: 171 epithelial ovarian cancer (83.4%), 20 primary peritoneal cancer (9.8%) and 14 fallopian tube cancer (6.8%).
Participant flow	From March 2020 to November 2020, 206 patients were entered in the full analysis set (FAS) and 205 patients were entered in the PPS.
Adverse events	NA
Outcome measures	Unpublished
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 11 Month 28 Day
Date of IRB	2020 Year 01 Month 23 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2020 Year 11 Month 13 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 09 Month 30 Day

Other

Other related information

<Study Design> This is a Japanese, multi-center, observational study. Patients with newly diagnosed FIGO stage III - IV OC after 1st January, 2019 will be enrolled sequentially. Patients those who have undergone or are planning to undergo BRACAnalysis, which detects BRCA mutations, are eligible for this study. In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. To reduce regional bias of study sites, the number of enrolled patients per site will be capped. The patient's clinical background information, sample collection information, etc. at enrollment will be collected and recorded from the medical records, etc. Archived formalin-fixed paraffin-embedded (FFPE) samples from enrolled patients will be forwarded to the central laboratories for BRCA testing according to Sample Handling Procedures. Histopathology will be assessed by the central pathologists using serial sections of the submitted samples. Summary of the rationale Although gBRCAm testing was approved in Japan, tBRCAm had not been approved yet. Additionally, limited epidemiological data on the prevalence of tBRCAm in OC patients exists in Japan. Therefore, the objective of this study is to investigate BRCA mutations and homologous recombination deficiency (HRD) score in patients with newly diagnosed advanced (at the first diagnosis of) OC.

Management information
Registered date	2020 Year 01 Month 22 Day
Last modified on	2022 Year 07 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044736