UMIN-CTR Clinical Trial

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

Patients with newly diagnosed (at the first diagnosis of) FIGO stage III - IV ovarian cancer (OC)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

AstraZeneca K.K.

Institute

Department

Personal name

Organization

AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Linical Co.,Ltd.

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

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

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）

Date of disclosure of the study information

2020

Year

01

Month

27

Day

URL releasing protocol

Unpublished

Publication of results

Unpublished

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

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 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.

Registered date

2020

Year

01

Month

22

Day

Last modified on

2022

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044736