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Ovarian CancerCRONUSNCT03203993

China Ovarian Cancer BRCA Testing Study

An observational study of Ovarian Cancer, run by AstraZeneca at 19 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective, multi-center, observational study, the primary objective is to evaluate the prevalence of gBRCA/sBRCAm in newly diagnosed ovarian cancer patients and explore ovarian cancer treatment outcomes of different BRCAm status Read more about this study

Who is it for?
Ages 18 to 130 years, women only
Conditions the study is for
Ovarian Cancer
How many people
29 participants
Where
19 sitesin 2 countries
Study dates
31 Jan 2018to 31 Mar 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 18 to 130 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: newly diagnosed epithelial ovarian cancer patients

Who may be able to join

  • Be able and willing to sign the informed consent form (ICF)
  • Female aged 18 years or over
  • Have histologically confirmed new diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made by one or more of the following:
  • standard staging laparotomy including bilateral salpingo-oophorectomy, omentectomy, and lymph node sampling and debulkingand/or
  • surgical resection and radiographic evidence consistent with Stage III or IV ovarian cancer
  • biopsy with radiographic evidence consistent with Stage III or IV ovarian cancer
  • Have availability of paraffin-embedded archivedtumor tissue block (preferred) or,if a block is not possible, a minimum of twenty 5-μm unstained sections. (Tumor tissue should be archived at diagnosis. 10 slides is utilized for sBRCA testing after the enrolment. Another 10 slides is utilized for exploratory evaluation of HRR gene mutations in a retrospective way.)
  • Have a diagnosis that is within 60 days of informed consent

Who cannot join

  • Have a diagnosis of additional concurrent malignancies or previous diagnosis of another malignancy with current evidence of residual disease
  • Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study
  • Be currently participating in any other clinical trial for first-line treatment of ovarian cancer
  • Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

China18 sites

  • Research Site

    Beijing, Beijing Municipality, 100142

  • Research Site

    Beijing, Beijing Municipality, 100191

  • Research Site

    Beijing, Beijing Municipality, 100730

  • Research Site

    Changsha, Hunan, 410000

  • Research Site

    Chengdu, Sichuan, 610041

  • Research Site

    Chongqing, Chongqing Municipality, 400030

  • Research Site

    Guangzhou, Guangdong, 510060

  • Research Site

    Guangzhou, Guangdong, 510080

  • Research Site

    Guangzhou, Guangdong, 510220

  • Research Site

    Hangzhou, Zhejiang, 310006

  • Research Site

    Hefei, Anhui, 230601

  • Research Site

    Jinan, Shandong, 250014

  • Research Site

    Shanghai, Shanghai Municipality, 200032

  • Research Site

    Shanghai, Shanghai Municipality, 200080

  • Research Site

    Tianjin, Tianjin Municipality, 300110

  • Research Site

    Tianjin, Tianjin Municipality, 300202

  • Research Site

    Wuhan, Hubei, 430030

  • Research Site

    Zhengzhou, Henan, 450008

Other trials in China

Hong Kong1 site

  • Research Site

    Hong Kong, 0

Other trials in Hong Kong

About this study

Official title: China Local BRCA Testing and Exploration of Ovarian Cancer Treatment Outcomes of Different BRCA Status in Newly Diagnosed Epithelial Ovarian Cancer Patients

This is a prospective, multi-center, observational study, the primary objective is to evaluate the prevalence of gBRCA/sBRCAm in newly diagnosed ovarian cancer patients and explore ovarian cancer treatment outcomes of different BRCAm status

Read the detailed description

This is a prospective, multi-center, observational study that will enroll consecutive patients with a confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or peritoneal cancer and who consent to a blood draw, a tissue sample analysis, and follow up for collection of data. 900 newly diagnosed ovarian cancer patients will be enrolled and evaluated for Breast Cancer Susceptibility genes BRCA1 and BRCA2 germline and somatic mutations (BRCAm). Approximately 170 BRCAm positive patients and 170 negative patients will be followed in the Follow-up Period. This study aims to answer very important questions regarding the prevalence of gBRCAm and sBRCAm in a population of newly diagnosed ovarian cancer patients, and the relationship of these mutations to patient treatment and clinical outcomes. These answers may be extremely helpful in the counseling and treatment of genetic risk in these populations and may aid in making treatment decisions in the future.

Conditions
Ovarian Cancer
Keywords
BRCA mutation
Medical subject headings
Ovarian Neoplasms

What is being measured

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

  1. Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations

    To evaluate the prevalence of gBRCA mutation and sBRCA mutation in newly diagnosed ovarian cancer patients

    Measured: 1 year

Secondary outcomes (2)

  1. Progression-free survival (PFS)

    To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of PFS

    Measured: 18 months

  2. Overall survival (OS)

    To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of OS

    Measured: up to 5 years

Timeline

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

  1. First posted29 Jun 2017
  2. Study start31 Jan 2018
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2020

Why it stopped: Failure to obtain HGR approval.

Resources

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
Case crossover
Time perspective
Prospective
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03203993
Sponsor's protocol ID
D133FR00117
Acronym
CRONUS
Status last verified
Oct 2020
First submitted
23 Jun 2017
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer, run by AstraZeneca at 19 sites in 2 countries.

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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China, Hong Kong. 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 was stopped early (reason given: Failure to obtain HGR approval.). Results are not available in the source record.

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?

Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations (time frame: 1 year). 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 NCT03203993.

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 14 Oct 2020.

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China Ovarian Cancer BRCA Testing Study (NCT03203993) | AzTrials