Ovarian CancerNCT03846856
The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance
An observational study of Ovarian Cancer, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to evaluate the insulin-like growth factor (IGF) axis involvement in the immune tumor microenvironment in ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Biopsy
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2019to Mar 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with epithelium ovarian cancer who have undergone or who plan to undergo surgery
Who may be able to join
- Women diagnosed with epithelium ovarian cancer who have undergone surgery
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Hagit Stolz, DVM, 972-7744335, hagitst@hy.health.gov.il
About this study
The aim of this study is to evaluate the insulin-like growth factor (IGF) axis involvement in the immune tumor microenvironment in ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- Biopsy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyOther
Biopsy taken during surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer patients | Biopsy will be taken from ovarian cancer patients and sent to laboratory for analysis Receives: Other: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Involvement of IGF Axis in Ovarian Cancer
Ovarian cancer specimens taken during surgical procedures will be evaluated and analyzed by flow cytometry assays to determine the involvement of the IGF axis in the immune tumor microenvironment in ovarian cancer
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study startApr 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilan Bruchim, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846856
- Sponsor's protocol ID
- HYMC-0080-18
- Status last verified
- Apr 2019
- First submitted
- 18 Feb 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance
- ClinicalTrials.gov ID
- NCT03846856
- Acronym / sponsor ID
- HYMC-0080-18
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 20 Feb 2019 (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.
The aim of this study is to evaluate the insulin-like growth factor (IGF) axis involvement in the immune tumor microenvironment in ovarian cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer patients | – | Other: BiopsyBiopsy will be taken from ovarian cancer patients and sent to laboratory for analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with epithelium ovarian cancer who have undergone or who plan to undergo surgery
Key inclusion criteria (1 listed)
- Women diagnosed with epithelium ovarian cancer who have undergone surgery
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyBiopsy taken during surgical procedure | Other | Ovarian cancer patients |
Primary outcome
Involvement of IGF Axis in Ovarian Cancer
Time frame: Two years
Ovarian cancer specimens taken during surgical procedures will be evaluated and analyzed by flow cytometry assays to determine the involvement of the IGF axis in the immune tumor microenvironment in ovarian cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Ilan Bruchim, MD principal investigator
Hillel Yaffe Medical Center
1 site 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 Hillel Yaffe Medical Center at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagit Stolz, DVM (972-4-7744335, hagitst@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Involvement of IGF Axis in Ovarian Cancer (time frame: Two years). 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 4 Apr 2019.