BRCA MutationSTICRISCNCT06393543
International Registration of Isolated STIC: to Report and Investigate the Risk of Serous Peritoneal Carcinomatosis
An observational study of BRCA Mutation and Serous Tubal Intraepithelial Carcinoma, run by Radboud University Medical Center.
Trial summary
To prospectively assess the incidence of peritoneal carcinomatosis for women with isolated STIC (serous tubal intraepithelial carcinoma). Moreover, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of peritoneal carcinomatosis and to report the findings of… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- BRCA Mutation, Serous Tubal Intraepithelial Carcinoma, Ovarian Carcinoma
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jun 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- Women only
- Adult, Older adult
Study population: For the retrospective cohort: All women with STIC diagnosed between 2015 and start of the prospective study are identified. Data up until that time-point will be collected. At the end of the data collection follow-up will be updated on the women in the retrospective cohort. For the prospective cohort: All consecutive women with isolated STIC from participating centres are informed on the study and requested to participate.
Who may be able to join
- Women
- Bilateral salpingectomy (with or without oophorectomy)
- A serous tubal intraepithelial carcinoma at histopathological review
Who cannot join
- Invasive cancer at initial surgery or pathological examination (either macroscopic and/or microscopic)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To prospectively assess the incidence of peritoneal carcinomatosis for women with isolated STIC (serous tubal intraepithelial carcinoma). Moreover, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of peritoneal carcinomatosis and to report the findings of additional diagnostics.
Read the detailed description
Women with a BRCA pathogenic variant (PV) undergo a risk-reducing salpingo-oophorectomy (RRSO) to reduce their ovarian cancer risk of 17-44%. A residual risk for peritoneal cancer (PC) persists, with most patients having extensive tumour spread throughout the abdomen. Despite surgery and chemotherapy, the five-year survival rate of PC is only 14-30%. Recently it became apparent that PC is frequently preceded by a preinvasive serous tubal intraepithelial cancer (STIC) at RRSO. The entity STIC is often found conjointly with ovarian cancer, but can also be present as an isolated condition, mostly in high risk women. If this STIC is found at RRSO, the risk for PC was found to be 27.5% (95% CI, 15.6-43.9) after ten years whilst this risk was <1% without STIC. The pathophysiological mechanism of this association is not yet known and it is unknown which women with STIC are most at risk. Moreover, the additional value of diagnostics and management is unknown as data is lacking.
Objective: To prospectively assess the PC incidence for women with isolated STIC, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of PC, and to report the findings of additional diagnostics.
- Conditions
- BRCA Mutation, Serous Tubal Intraepithelial Carcinoma, Ovarian Carcinoma, Peritoneal Carcinoma
- Being tested
- No intervention, only registration
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, only registrationOther
No intervention, only registration
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Women with isolated STIC diagnosed between 2015 and the start of the study. Receives: Other: No intervention, only registration | |
| Prospective cohort | Women with a newly diagnosed isolated STIC Receives: Other: No intervention, only registration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk for peritoneal carcinomatosis in women with isolated STIC
Measured: 10 years
Secondary outcomes (3)
Risk factors
Risk for PC in relation to patient characteristics such as age at diagnosis and presence of a genetic pathogenic variant.
Measured: 5-10 years
Histopathological characteristics
Identification of histopathological characteristics of STIC which are reproducible and associated to the risk of PC.
Measured: 5-10 years
Additional diagnostics
To report findings at additional diagnostics (ie. imaging, staging surgery, CA125).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2034 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA MutationStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393543
- Sponsor's protocol ID
- 2024-17277
- Acronym
- STICRISC
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In collaboration with participating centers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registration of Isolated STIC: to Report and Investigate the Risk of Serous Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT06393543
- Acronym / sponsor ID
- STICRISC / 2024-17277
- Conditions
- BRCA Mutation, Serous Tubal Intraepithelial Carcinoma, Ovarian Carcinoma, Peritoneal Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2034 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 1 May 2024 (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.
To prospectively assess the incidence of peritoneal carcinomatosis for women with isolated STIC (serous tubal intraepithelial carcinoma). Moreover, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of peritoneal carcinomatosis and to report the findings of additional diagnostics.
Detailed description
Women with a BRCA pathogenic variant (PV) undergo a risk-reducing salpingo-oophorectomy (RRSO) to reduce their ovarian cancer risk of 17-44%. A residual risk for peritoneal cancer (PC) persists, with most patients having extensive tumour spread throughout the abdomen. Despite surgery and chemotherapy, the five-year survival rate of PC is only 14-30%. Recently it became apparent that PC is frequently preceded by a preinvasive serous tubal intraepithelial cancer (STIC) at RRSO. The entity STIC is often found conjointly with ovarian cancer, but can also be present as an isolated condition, mostly in high risk women. If this STIC is found at RRSO, the risk for PC was found to be 27.5% (95% CI, 15.6-43.9) after ten years whilst this risk was <1% without STIC. The pathophysiological mechanism of this association is not yet known and it is unknown which women with STIC are most at risk. Moreover, the additional value of diagnostics and management is unknown as data is lacking.
Objective: To prospectively assess the PC incidence for women with isolated STIC, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of PC, and to report the findings of additional diagnostics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Other: No intervention, only registrationWomen with isolated STIC diagnosed between 2015 and the start of the study. |
| Prospective cohort | – | Other: No intervention, only registrationWomen with a newly diagnosed isolated STIC |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- For the retrospective cohort: All women with STIC diagnosed between 2015 and start of the prospective study are identified. Data up until that time-point will be collected. At the end of the data collection follow-up will be updated on the women in the retrospective cohort. For the prospective cohort: All consecutive women with isolated STIC from participating centres are informed on the study and requested to participate.
Key inclusion criteria (3 listed)
- Women
- Bilateral salpingectomy (with or without oophorectomy)
- A serous tubal intraepithelial carcinoma at histopathological review
Key exclusion criteria (1 listed)
- Invasive cancer at initial surgery or pathological examination (either macroscopic and/or microscopic)
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 |
|---|---|---|
| No intervention, only registrationNo intervention, only registration | Other | Prospective cohort, Retrospective cohort |
Primary outcome
The risk for peritoneal carcinomatosis in women with isolated STIC
Time frame: 10 years
3 secondary outcomes
Risk factors
Time frame: 5-10 years
Histopathological characteristics
Time frame: 5-10 years
Additional diagnostics
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: Yes. In collaboration with participating centers upon reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of BRCA Mutation and Serous Tubal Intraepithelial Carcinoma, run by Radboud University Medical Center.
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 3 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: opening soon, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miranda Steenbeek, MD PhD (0031615909405, miranda.steenbeek@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The risk for peritoneal carcinomatosis in women with isolated STIC (time frame: 10 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 1 May 2024.