Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA

An observational study of Ovarian Cancer, run by AstraZeneca at 35 sites in Japan.

Completed

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

Trial summary

The multi-centered, cross-sectional investigations shall be conducted in this study with the objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan. Read more about this study

Who is it for?: Ages 20 to 130 years, women only
Conditions the study is for: Ovarian Cancer
How many people: 446 participants
Where: 35 sitesJapan
Study dates: 26 Dec 2016to 6 Jul 2018
How long will I take part?: 1 Day
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 to 130 years
Women only
No healthy volunteers
Adult, Older adult

Study population: The newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.

Who may be able to join

For registration to this study, all of the following criteria should be satisfied:
The subject can attach the signature to the Informed Consent Form (ICF), besides having his/her intention to put the signature.
Female Japanese at more than 20 years of age
The newly diagnosed patients whose epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer is histologically confirmed as FIGO from the subject to obtain their utmost understandings. Limited to histopathological diagnosis based on resected tumor specimens (except the cytodiagnosis by ascites paracentesis).
The histopathological specimens can be submitted to the central pathological judgment.
Within 60 days after diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, the patient's written consent has been obtained.

Who cannot join

The subjects who coincide any of the following exclusion criteria are designated to be ineligible:
In case of the subjects who are diagnosed to have acute or chronic physical or severe mental diseases except cancer, and about whom the attending responsible physician makes judgement to say that participation of these subjects would possibly increase the risks or would probably disturb the interpretation of the study results.
In case of the subjects whose registration for the study is judged by the attending responsible physician as inappropriate.

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

Japan35 sites

Research Site
Aichi
Research Site
Akita
Research Site
Aomori
Research Site
Chiba
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Gifu
Research Site
Hyōgo
Research Site
Ibaraki
Research Site
Izumo
Research Site
Kanagawa
Research Site
Kumamoto
Research Site
Kyoto
Research Site
Maebashi
Research Site
Matsuyama
Research Site
Mie
Research Site
Miyagi
Research Site
Morioka
Research Site
Nagano
Research Site
Nagasaki
Research Site
Nara
Research Site
Niigata
Research Site
Okayama
Research Site
Okinawa
Research Site
Osaka
Research Site
Saga
Research Site
Saitama
Research Site
Sapporo
Research Site
Sendai
Research Site
Tochigi
Research Site
Tokushima
Research Site
Tokyo
Research Site
Tōon
Research Site
Tottori
Research Site
Yamagata

Other trials in Japan

About this study

Official title: Japan CHARLOTTE: Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA

Read the detailed description

This multi-centered, cooperative and epidemiological observation study is so designed to investigate the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer because such a ratio has not yet been adequately clarified in Japan.

The newly diagnosed eligible patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer shall be asked to participate in this study in order of diagnosis. After obtaining their consents by the written informed consent following appropriate explanation, investigations about the demographic information including the cancer family history shall be performed. Subsequently, blood is collected for investigation about gBRCAm. In addition, histological classification shall be conducted based on the resected tumor tissues.

Conditions: Ovarian Cancer
Keywords: ovarian cancer, gBRCAm
Medical subject headings: Ovarian Neoplasms

What is being measured

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

Assessment of the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.
To be evaluated based on laboratory test.
Measured: Baseline

Secondary outcomes (2)

Ownership ratio of gBRCAm when stratified according to the patients' demographics
To be evaluated by laboratory test
Measured: Baseline
Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing
To be evaluated by questionnaire
Measured: Baseline

Timeline

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

26 Dec 20166 Jul 2018

First posted25 Jul 2017
Study start26 Dec 2016
Primary completion6 Jul 2018
Study completion6 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ovarian CancerStudies 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: Cohort
Time perspective: Cross-sectional
Enrolment: 446 participants (estimated)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT03229122
Sponsor's protocol ID: D0816R00013
Acronym: CHARLOTTE
Status last verified: Jun 2019
First submitted: 2 Jun 2017
Last updated: 10 Jun 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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 Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Japan CHARLOTTE: Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA
ClinicalTrials.gov ID: NCT03229122
Acronym / sponsor ID: CHARLOTTE / D0816R00013
Conditions: Ovarian Cancer
Keywords: ovarian cancer, gBRCAm
Study type: Observational
Recruitment status: Completed
Enrolment: 446 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 26 Dec 2016 (actual)
Primary completion: 6 Jul 2018 (actual)
Study completion: 6 Jul 2018 (actual)
First posted: 25 Jul 2017 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Target follow-up: 1 Day

Who may qualify

Ages: 20 to 130 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.

Key inclusion criteria (6 listed)

The subject can attach the signature to the Informed Consent Form (ICF), besides having his/her intention to put the signature.
Female Japanese at more than 20 years of age
The newly diagnosed patients whose epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer is histologically confirmed as FIGO from the subject to obtain their utmost understandings. Limited to histopathological diagnosis based on resected tumor specimens (except the cytodiagnosis by ascites paracentesis).
The histopathological specimens can be submitted to the central pathological judgment.
Within 60 days after diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, the patient's written consent has been obtained.

Key exclusion criteria (3 listed)

The subjects who coincide any of the following exclusion criteria are designated to be ineligible:

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

Assessment of the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.
Time frame: Baseline
To be evaluated based on laboratory test.

2 secondary outcomes

Ownership ratio of gBRCAm when stratified according to the patients' demographics
Time frame: Baseline
Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing
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 10 Jun 2019.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Ovarian Cancer

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.

Toru Sugiyama, MD principal investigator

Iwate Medical University

Daisuke Aoki, MD study director

Keio University

Takayuki Enomoto, MD. PhD. study director

School of Medicine, Niigata University

35 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 Cancer, run by AstraZeneca at 35 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 6 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: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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?

Assessment of the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan. (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 NCT03229122.

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 10 Jun 2019.