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Ovarian NeoplasmsINFORMNCT04460768

An INternational Frontline Ovarian Cancer Real World Management Study

An observational study of Ovarian Neoplasms, run by AstraZeneca at 4 sites in 3 countries.

Completed

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

Official record
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Trial summary

The current study aims to analyze the existing secondary databases from Korea (Sungkyunkwan University, Samsung Medical Center, Seoul), Taiwan (National Taiwan University, Chang-Gung Medical Foundation Linkou Branch and Mackay Memorial Hospital), and Australia (Australian Ovarian Cancer Study [AOCS]) to leverage the… Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Ovarian Neoplasms
How many people
989 participants
Where
4 sitesin 3 countries
Study dates
27 Jun 2020to 10 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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: This is a non-interventional study that involves retrospective collection of data from medical records of all patients who have been newly diagnosed with advanced-stage epithelial ovarian cancer (high grade serous type epithelial ovarian cancer for Taiwan) between the period Jan 2014-Dec 2018.

Who may be able to join

  • Female subjects above the age of 18
  • Patients with a confirmed diagnosis of advanced-stage (FIGO III/IV) epithelial (Serous [high or low grade], mucinous, endometrioid, clear cell, mixed, and others) ovarian cancer between the period Jan 2014 and Dec 2018, provided at least 12 months data is available (not mandatory to be ovarian cancer related) as a proxy of healthcare use prior to the diagnosis of advanced-stage epithelial ovarian cancer

Who cannot join

  • Patients being included in interventional clinical trials with PARPi for the treatment of advanced-stage high-grade epithelial ovarian cancer treatment during the study period
  • Patients with early stage disease (FIGO Stage I, IIA, IIB, or IIC)
  • Other malignancies within the past five years, except adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ; stage 1, grade 1 endometrial carcinoma; or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years. Patients with a history of localized breast cancer may have been eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and remained free of recurrent or metastatic disease

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Taiwan2 sites
  • Research Site

    New Taipei City, D0817R00028

  • Research Site

    Taipei, D0817R00028

Other trials in Taiwan

Australia1 site
  • Research Site

    Melbourne, Victoria, D0817R00028

Other trials in Australia

South Korea1 site
  • Research Site

    Seoul, D0817R00028

Other trials in South Korea

About this study

Official title: A Multicountry, Multicenter, Retrospective Study Evaluating the Patient Characteristics, Disease Burden, Treatment Patterns, and Patient Journey of Advanced Epithelial Ovarian Cancer Patients: A Korean, Taiwanese, and Australian Secondary Database Study

The current study aims to analyze the existing secondary databases from Korea (Sungkyunkwan University, Samsung Medical Center, Seoul), Taiwan (National Taiwan University, Chang-Gung Medical Foundation Linkou Branch and Mackay Memorial Hospital), and Australia (Australian Ovarian Cancer Study [AOCS]) to leverage the already available data in the real-world setting to review the current standard of care in advanced epithelial ovarian cancer cases. The collected data will help provide the required information for assessing the unmet treatment needs in this patient group. The data will also provide the needed information to support any reimbursement activity needed for future novel therapies in this patient group

Read the detailed description

Ovarian cancer is the eighth most commonly diagnosed cancer (295,414 cases reported in 2018) and the seventh leading cause of cancer-associated mortality (184,799 deaths reported in 2018) in women, worldwide. The increasing trends in the burden of ovarian cancer, coupled with other challenges, such as lack of awareness of ovarian cancer risk factors, lack of adequate screening tools, lack of access to diagnostics, and lack of trained clinicians, contribute to delays in diagnosis, resulting in a high proportion of patients presenting with advanced-stage ovarian cancer associated with high mortality. Over 75% of women with ovarian cancer have been reported to be diagnosed at a late stage with high relapse rates, despite first-line therapy. Studies in Asia have highlighted that about 65%-70% of women with ovarian cancer are diagnosed at an advanced stage. Further, the five-year net survival rate of advanced-stage ovarian cancer in Asia has been found to range from 14% to 41%.

Among the various ovarian cancer subtypes based on histology, epithelial ovarian cancer is the most common type, reported in about 90% of cases. Specifically, type II epithelial ovarian cancer (that includes serous carcinoma, mixed epithelial and stromal carcinoma, undifferentiated carcinomas, and other epithelial carcinoma) accounts for about 66%-73%, 56%, 73%, and 73% in the US, Asia, Europe, and Oceania, respectively. The corresponding rates for type I epithelial ovarian tumors (that include endometrioid, clear cell, mucinous, squamous, and transitional cell carcinomas) have been noted to be 19%-21%, 32.5%, 20.5%, and 20%, respectively. Regarding prognosis, the five-year net survival rate of type II epithelial ovarian cancer that includes serous carcinoma has been found to be low when compared to other subtypes across all regions. Of note, type II epithelial ovarian tumors have been reported to be highly aggressive and usually present at an advanced stage, with poor survival rates. The recurrence or relapse rates have also been noted to be high with epithelial serous ovarian cancer. Furthermore, a strong association has been noted between family history of ovarian cancer, a very strong risk factor, and the risk of developing aggressive serous carcinomas. Genetic (both germline and somatic) mutations in BRCA1/2 have been noted in about 22% of high-grade, serous, ovarian carcinomas, and the majority of hereditary cases (~44%). Also, mutations in homologous recombination response genes have been noted in about 50% of high-grade serous epithelial ovarian cancer cases.

Considering the high incidence, poor prognosis, and high morbidity and mortality from advanced epithelial ovarian cancer, it is important to have well-organized databases on the clinical characteristics, treatment patterns, and outcomes of these patients, to help identify the unmet needs and gaps and further optimize the survival outcomes in these patients. With exception of the UK, France, Germany, Italy, and Spain and the USA, there is paucity of databases, registries, or published literature on patient level data pertaining to treatment patterns, clinical characteristics, and outcomes of advanced ovarian cancer patients. Therefore, the current study aims to analyze the existing secondary databases from Korea (Sungkyunkwan University, Samsung Medical Center, Seoul), Taiwan (National Taiwan University, Chang-Gung Medical Foundation Linkou Branch and Mackay Memorial Hospital), and Australia (Australian Ovarian Cancer Study) to leverage the already available data in the real-world setting to review the current standard of care in advanced epithelial ovarian cancer cases. The collected data will help provide the required information for assessing the unmet treatment needs in this patient group. The data will also provide the needed information to support any reimbursement activity needed for future novel therapies in this patient group.

Medical subject headings
Ovarian Neoplasms

What is being measured

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

  1. Progression-free survival

    In first line setting - length of time from diagnosis to first progression, death, or last follow-up. In second line setting, length of time from start of second line therapy until patient has disease progression, death, or last follow-up.

    Measured: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Secondary outcomes (5)
  1. Platinum free interval

    The number of months elapsed from the last day of platinum chemotherapy for first line of treatment to the date of diagnosis of disease recurrence or date of last follow-up if the patient did not recur during the study period

    Measured: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

  2. Time to progression

    The length of time from the date of cancer diagnosis or the start of anti-cancer treatment until the cancer starts to get worse or spread to other parts of the body.

    Measured: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

  3. Duration of treatment

    The length of time from the start of anti-cancer treatment to end of anti-cancer treatment

    Measured: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

  4. Time to first subsequent treatment

    The length of time from the date of cancer diagnosis to the start of cancer treatment after cancer progression

    Measured: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

  5. Overall survival

    Duration from the index date to the date of death (if available)

    Measured: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Timeline

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

  1. First posted8 Jul 2020
  2. Study start27 Jun 2020
  3. Primary completion10 Nov 2020
  4. Study completion10 Nov 2020

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
Other
Time perspective
Retrospective
Enrolment
989 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04460768
Sponsor's protocol ID
D0817R00028
Acronym
INFORM
Status last verified
Sep 2021
First submitted
3 Jul 2020
Last updated
27 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Neoplasms, run by AstraZeneca at 4 sites in 3 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 2 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 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Taiwan, Australia, South Korea. 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?

Progression-free survival (time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Sep 2021.

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