Ovarian NeoplasmsCHRISTELLENCT04222465

Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients

An observational study of Ovarian Neoplasms, run by AstraZeneca at 20 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially. In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. Read more about this study

Who is it for?: Ages 20 years and older, women only
Conditions the study is for: Ovarian Neoplasms
How many people: 207 participants
Where: 20 sitesJapan
Study dates: 19 Mar 2020to 13 Nov 2020
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 20 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

Aged 20 years or older of Japanese women at the time of consent (the age of death, in case of dead patient)
Newly diagnosed as advanced OC (FIGO stage III - IV) with epithelial ovarian cancer, primary peritoneal cancer or fallopian-tube cancer [or a combination of these cancers] after January 1, 2019
Patients who have archived formalin-fixed paraffin-embedded (FFPE) samples of primary or peritoneal metastatic tumor collected after January 1, 2019
Patients who have undergone or are scheduled to undergo BRACAnalysis
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.)

Who cannot join

Patients who are not recommended enrolling this study decided by physician

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Japan20 sites

Research Site
Amagasaki, Hyōgo
Research Site
Bunkyo, Tokyo
Research Site
Fukushima
Research Site
Gifu
Research Site
Izumo, Shimane
Research Site
Kashihara, Nara
Research Site
Kitakyushu, Fukuoka
Research Site
Kobe, Hyōgo
Research Site
Kumamoto
Research Site
Matsuyama, Ehime
Research Site
Minato, Tokyo
Research Site
Musashino, Tokyo
Research Site
Niigata
Research Site
Sapporo, Hokkaido
Research Site
Sendai, Miyagi
Research Site
Shinjuku, Tokyo
Research Site
Tōon, Ehime
Research Site
Tsukuba, Ibaraki
Research Site
Yamagata
Research Site
Yoshida, Fukui

Other trials in Japan

About this study

This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially.

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

Read the detailed description

Study design:This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially.

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.

Study population:Patients with FIGO stage III - IV epithelial ovarian cancer Drug exposure:Not applicable Planned study sites and sample size:The objective number of patients will be 200 from approximately 20 hospitals.

Conditions: Ovarian Neoplasms
Keywords: Advanced ovarian cancer, BRCA1/2
Medical subject headings: Ovarian Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

The prevalence of tBRCAm in the newly diagnosed advanced OC patients
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) / favour polymorphism / no mutation detected
Measured: Baseline

Secondary outcomes (3)

The prevalence of gBRCAm in the subjects
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) / favour polymorphism / no mutation detected
Measured: Baseline
The prevalence of sBRCAm in the subjects
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
Measured: Baseline
The ratio of sBRCAm out of tBRCAm
Calculate the rate of sBRCAm out of tBRCAm
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 202013 Nov 2020

First posted10 Jan 2020
Study start19 Mar 2020
Primary completion13 Nov 2020
Study completion13 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ovarian NeoplasmsStudies 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: Cross-sectional
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04222465
Sponsor's protocol ID: D0817R00018
Acronym: CHRISTELLE
Status last verified: Oct 2021
First submitted: 7 Jan 2020
Last updated: 26 Oct 2021
Results posted: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

All Ovarian Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients
ClinicalTrials.gov ID: NCT04222465
Acronym / sponsor ID: CHRISTELLE / D0817R00018
Conditions: Ovarian Neoplasms
Keywords: Advanced ovarian cancer, BRCA1/2
Study type: Observational
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 19 Mar 2020 (actual)
Primary completion: 13 Nov 2020 (actual)
Study completion: 13 Nov 2020 (actual)
First posted: 10 Jan 2020 (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.

This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially.

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

Detailed description

Study design:This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially.

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.

Study design

Observational model: Other
Time perspective: Cross-sectional

Who may qualify

Ages: 20 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (5 listed)

Aged 20 years or older of Japanese women at the time of consent (the age of death, in case of dead patient)
Newly diagnosed as advanced OC (FIGO stage III - IV) with epithelial ovarian cancer, primary peritoneal cancer or fallopian-tube cancer [or a combination of these cancers] after January 1, 2019
Patients who have archived formalin-fixed paraffin-embedded (FFPE) samples of primary or peritoneal metastatic tumor collected after January 1, 2019
Patients who have undergone or are scheduled to undergo BRACAnalysis
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 listed)

Patients who are not recommended enrolling this study decided by physician

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 prevalence of tBRCAm in the newly diagnosed advanced OC patients
Time frame: Baseline
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) / favour polymorphism / no mutation detected

3 secondary outcomes

The prevalence of gBRCAm in the subjects
Time frame: Baseline
The prevalence of sBRCAm in the subjects
Time frame: Baseline
The ratio of sBRCAm out of tBRCAm
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 26 Oct 2021.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Related trials for Ovarian Neoplasms

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

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.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Neoplasms, run by AstraZeneca at 20 sites in Japan.

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 5 inclusion and 1 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Japan. 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 prevalence of tBRCAm in the newly diagnosed advanced OC patients (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 NCT04222465.

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 26 Oct 2021.