Endometrial CancerNCT06294886
Vaginal Fluid Collection for Detection of Endometrial Cancer
An observational study of Endometrial Cancer, run by Innovis LLC at 1 site in United States.
Trial summary
The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Screening test to detect endometrial cancer and precancer
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to 1 Jun 2024
- 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: The study will enroll women ≥18 years of age with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia, or endometrial intraepithelial neoplasia (EIN) presenting for management of their endometrial pathology.
Who may be able to join
- Women ≥18 years of age.
- Women with endometrial tissue biopsy-based histopathological diagnosis of EC (any histology, including uterine carcinosarcoma), AEH or EIN.
- Women whose planned surgical intervention (if any) includes hysterectomy, D\&C, or hysteroscopic resection.
- Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
- -
Who cannot join
- Patient with recurrent and/or previously treated EC.
- Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis prior to study enrollment.
- Prior hysterectomy.
- Current known pregnancy diagnosis.
- Prior or current biopsy and histopathology-proven cervical cancer.
- The presence of concomitant biopsy and histopathology-proven cervical dysplasia.
Show all 10Show fewer
- Any prior pelvic or vaginal radiotherapy.
- Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years.
- Chemotherapy within the past 5 years.
- Prior intervention to treat, or surgery with intent to completely remove, the target pathology for the current diagnosis during the current episode.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Trials365
Shreveport, Louisiana, 71118
Jen Cory, 318-408-1198, j.cory@trials365.org
Destin Black, MD
About this study
Official title: Vaginal Fluid Collection Study for Endometrial Cancer Test Research and Development
The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).
The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN.
Read the detailed description
For participants providing written informed consent to participate in the study, samples of vaginal fluid will be obtained by the Principal Investigator (PI) during a pelvic examination. All vaginal fluid samples will be collected ≥7 days after the endometrial biopsy and prior to initiating any therapeutic interventions including surgery, chemotherapy, radiation or hormonal therapy PIs will be provided with multiple, individually packaged Copan eNat® sterile sample collection kits including a swab and a transport tube containing a stabilizer and preservative medium as well as a pre-addressed shipping container and single-use tubes of sterile saline solution After vaginal fluid sample collection, the swab will be inserted into the tube for storage and subsequent shipping to the Sponsor's designated laboratory. The samples can be stored at ambient temperature and should be shipped to the designated laboratory within 24 hours of collection. Site(s) will provide the Sponsor with de-identified endometrial biopsy histopathology report and post-surgery histopathology report (if any) confirming the histopathological diagnosis of EC, AEH or EIN. The final diagnosis will be based on the most severe clinical histopathology (at diagnostic endometrial sampling or surgery.)
- Conditions
- Endometrial Cancer
- Being tested
- Screening test to detect endometrial cancer and precancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening test to detect endometrial cancer and precancerDiagnostic test
The device is designed to detect DNA biomarkers for cancer in cells shed from the lining of the uterus into vaginal fluid
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of endometrial cancer and precancer
To provide vaginal fluid specimens to Exact Sciences Corporation to allow for additional research and development of a screening device for the detection of endometrial cancer and endometrial hyperplasia with atypia.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start19 Feb 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg S Britt, Study director, Innovis LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294886
- Sponsor's protocol ID
- Innovis RD-2401
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Fluid Collection Study for Endometrial Cancer Test Research and Development
- ClinicalTrials.gov ID
- NCT06294886
- Acronym / sponsor ID
- Innovis RD-2401
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Innovis LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 6 Mar 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.
The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).
The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN.
Detailed description
For participants providing written informed consent to participate in the study, samples of vaginal fluid will be obtained by the Principal Investigator (PI) during a pelvic examination. All vaginal fluid samples will be collected ≥7 days after the endometrial biopsy and prior to initiating any therapeutic interventions including surgery, chemotherapy, radiation or hormonal therapy PIs will be provided with multiple, individually packaged Copan eNat® sterile sample collection kits including a swab and a transport tube containing a stabilizer and preservative medium as well as a pre-addressed shipping container and single-use tubes of sterile saline solution After vaginal fluid sample collection, the swab will be inserted into the tube for storage and subsequent shipping to the Sponsor's designated laboratory. The samples can be stored at ambient temperature and should be shipped to the designated laboratory within 24 hours of collection. Site(s) will provide the Sponsor with de-identified endometrial biopsy histopathology report and post-surgery histopathology report (if any) confirming the histopathological diagnosis of EC, AEH or EIN. The final diagnosis will be based on the most severe clinical histopathology (at diagnostic endometrial sampling or surgery.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll women ≥18 years of age with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia, or endometrial intraepithelial neoplasia (EIN) presenting for management of their endometrial pathology.
Key inclusion criteria (5 listed)
- Women ≥18 years of age.
- Women with endometrial tissue biopsy-based histopathological diagnosis of EC (any histology, including uterine carcinosarcoma), AEH or EIN.
- Women whose planned surgical intervention (if any) includes hysterectomy, D\&C, or hysteroscopic resection.
- Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
- -
Key exclusion criteria (10 listed)
- Patient with recurrent and/or previously treated EC.
- Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis prior to study enrollment.
- Prior hysterectomy.
- Current known pregnancy diagnosis.
- Prior or current biopsy and histopathology-proven cervical cancer.
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 |
|---|---|---|
| Screening test to detect endometrial cancer and precancerThe device is designed to detect DNA biomarkers for cancer in cells shed from the lining of the uterus into vaginal fluid | Diagnostic test | – |
Primary outcome
Detection of endometrial cancer and precancer
Time frame: 4 months
To provide vaginal fluid specimens to Exact Sciences Corporation to allow for additional research and development of a screening device for the detection of endometrial cancer and endometrial hyperplasia with atypia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- 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.
Gregg S Britt study director
Innovis LLC
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 Endometrial Cancer, run by Innovis LLC at 1 site in United States.
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 5 inclusion and 10 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 7 Mar 2024. 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 United States. 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 Wallis Blumm (9172082989, wblumm@innovis.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of endometrial cancer and precancer (time frame: 4 months). 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 7 Mar 2024.