Endometrial CancerDETECTRNCT06268626
Detection of Endometrial Cancer Through Risk Modelling
An observational study of Endometrial Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
The study goal is to investigate a non-invasive approach to predict endometrial cancer (EC) risk, better understand disease progression and identify opportunities for intervention. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 10 Oct 2024to Jan 2027
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study investigators will have 10-15 study gynecologists across British Columbia, Canada, who will be recruiting study participants from patients who are referred to them for an endometrial biopsy due to abnormal uterine bleeding. The investigators aim to recruit ~1000 participants in Study Part A in order to achieve their target sample size of n=50 EIN/EC and n=150 EH. Sequenced participants will be invited to participate in Study Part B/ Longitudinal monitoring and provide additional samples.
Who may be able to join
- Study Part A:
- 40 years and older
- Experiencing unexplained abnormal uterine bleeding (i.e., not from IUD, etc.)
- Have an intact uterus
- Referred for an endometrial biopsy
- Study Part B/Longitudinal monitoring:
- Those selected for sequencing (from Part A) and who retained their uterus.
Who cannot join
- Study Part A:
- Endometrial sampling, pelvic radiation, or vaginal infection (vaginosis, yeast) in the past 3 months
- Started hormone therapy (HRT, birth control, IUD) in the past year (with the exception of tamoxifen)
- Intercourse, vaginal product use, or douching in the past 48 hours
- Study Part B/Longitudinal monitoring:
- Same as Study Part A
- EC or EIN, or anyone who is recommended a hysterectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
VGH Research Pavilion
Vancouver, British Columbia, V5Z 1M9
Aline Talhouk, PhD, +1 (604) 875-4111 ext. 21365, a.talhouk@ubc.ca
Jennifer Ellis-White, BSc, +1 (604) 875-4111 ext. 21369, jelliswh@student.ubc.ca
About this study
Official title: Non-Invasive Strategies for Early Detection of Uterine Cancer in Patients With Abnormal Uterine Bleeding
The study goal is to investigate a non-invasive approach to predict endometrial cancer (EC) risk, better understand disease progression and identify opportunities for intervention.
This two-part case-cohort prospective study will recruit patients whose abnormal uterine bleeding is being evaluated via endometrial biopsy. Participants will complete an online health questionnaire, and a subset will be invited to self-collect vaginal samples for sequencing.
Selected sequenced participants will be invited for longitudinal monitoring (questionnaires, wearable fitness tracker) and an additional vaginal self-collection to identify persistent genetic mutations or microbiome alterations 6-8 months later.
Read the detailed description
Purpose:
To improve the prediction of EC and its precursors by integrating data from questionnaires and biological biomarkers obtained from non-invasive tests (vaginal DNA and microbiome swabs, vaginal pH). We also want to better understand pre-malignant disease progression and identify opportunities for earlier intervention.
Hypotheses:
- Risk factors in combination with ultrasound data, and patterns of abnormal bleeding are associated with endometrial cancer and its precursors.
- Prediction of pathology is improved by including mutation and microbiome data from noninvasive tests combined with traditional risk factors.
- Persistence of mutations and microbiome alterations is more common in patients with endometrial hyperplasia than other benign diagnoses and is associated with lifestyle factors.
Justification:
Non-invasive tests and questionnaires may be used to predict onset of endometrial carcinoma or its precursors and can be used to triage those participants with abnormal bleeding who require an endometrial biopsy.
Objectives:
To enhance understanding of the progression of EC and propose non-invasive methods for detection in patients who are experiencing abnormal uterine bleeding and have already been referred to a gynecologist for an endometrial biopsy.
Research Design:
This is a prospective case-cohort study that will recruit n=1000+ participants over the age of 35 years whose abnormal uterine bleeding is being evaluated via endometrial biopsy. Prospective participants will consent to access the information in their medical records, including access to their pathology report. A subset of participants (n=450) will be invited to self-collect vaginal DNA and microbiome samples using swabs and vaginal pH using a litmus kit for sequencing and analysis. A subset of those who retain their uterus (i.e. are not directed to a hysterectomy per standard clinical management) (n=200+), will be invited to take part in longitudinal monitoring using a wearable fitness tracker (Fitbit) and questionnaires, and an additional vaginal self-collection.
- Conditions
- Endometrial Cancer
- Keywords
- Screening, Prevention, Women's Health, Reproductive health, Abnormal Uterine Bleeding
- Medical subject headings
- Endometrial Neoplasms, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EIN/EC BIOPSY RESULT | Vaginal samples sequenced. Participation ends here. | |
| EH BIOPSY RESULT | Vaginal samples sequenced. Subset invited to move on to longitudinal monitoring and samples sequenced for 6 additional months. | |
| NEGATIVE BIOPSY RESULT | Control for natural and spontaneous changes in vaginal samples sequenced. Random subset selected to move on to longitudinal monitoring and samples sequenced for 6 additional months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of cfDNA Mutation Detection for Endometrial Pathology
Cell-free DNA (cfDNA) extracted from vaginal swabs will be sequenced to identify endometrial cancer-associated mutations. Diagnostic performance will be evaluated by calculating sensitivity, specificity, accuracy, positive predictive value, and negative predictive value for detecting endometrial pathology, using biopsy-confirmed pathology as the reference standard.
Measured: Through study completion, anticipated 1-2 years
Association Between Vaginal Microbiome Profile and Endometrial Pathology
Vaginal microbiome DNA extracted from swabs will be sequenced and processed into operational taxonomic units (OTUs) using an in-house bioinformatics pipeline. OTUs will be compared across biopsy-confirmed pathology groups and evaluated against previously published microbiome signatures predictive of endometrial cancer.
Measured: Through study completion, anticipated 1-2 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 2024
- Study start10 Oct 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Aline Talhouk, University of British Columbia
- Investigators
- Aline Talhouk, PhD, Principal investigator, University of British ColumbiaAnna Tinker, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268626
- Sponsor's protocol ID
- H22-02426
- Other IDs
- F22-01302, F21-03695
- Acronym
- DETECTR
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pfeiffer RM, Park Y, Kreimer AR, Lacey JV Jr, Pee D, Greenlee RT, Buys SS, Hollenbeck A, Rosner B, Gail MH, Hartge P. Risk prediction for breast, endometrial, and ovarian cancer in white women aged 50 y or older: derivation and validation from population-based cohort studies. PLoS Med. 2013;10(7):e1001492. doi: 10.1371/journal.pmed.1001492. Epub 2013 Jul 30.
PubMed 23935463
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Strategies for Early Detection of Uterine Cancer in Patients With Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT06268626
- Acronym / sponsor ID
- DETECTR / H22-02426
- Conditions
- Endometrial Cancer
- Keywords
- Screening, Prevention, Women's Health, Reproductive health, Abnormal Uterine Bleeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Feb 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 study goal is to investigate a non-invasive approach to predict endometrial cancer (EC) risk, better understand disease progression and identify opportunities for intervention.
This two-part case-cohort prospective study will recruit patients whose abnormal uterine bleeding is being evaluated via endometrial biopsy. Participants will complete an online health questionnaire, and a subset will be invited to self-collect vaginal samples for sequencing.
Selected sequenced participants will be invited for longitudinal monitoring (questionnaires, wearable fitness tracker) and an additional vaginal self-collection to identify persistent genetic mutations or microbiome alterations 6-8 months later.
Detailed description
Purpose:
To improve the prediction of EC and its precursors by integrating data from questionnaires and biological biomarkers obtained from non-invasive tests (vaginal DNA and microbiome swabs, vaginal pH). We also want to better understand pre-malignant disease progression and identify opportunities for earlier intervention.
Hypotheses:
- Risk factors in combination with ultrasound data, and patterns of abnormal bleeding are associated with endometrial cancer and its precursors.
- Prediction of pathology is improved by including mutation and microbiome data from noninvasive tests combined with traditional risk factors.
- Persistence of mutations and microbiome alterations is more common in patients with endometrial hyperplasia than other benign diagnoses and is associated with lifestyle factors.
Justification:
Non-invasive tests and questionnaires may be used to predict onset of endometrial carcinoma or its precursors and can be used to triage those participants with abnormal bleeding who require an endometrial biopsy.
Objectives:
To enhance understanding of the progression of EC and propose non-invasive methods for detection in patients who are experiencing abnormal uterine bleeding and have already been referred to a gynecologist for an endometrial biopsy.
Research Design:
This is a prospective case-cohort study that will recruit n=1000+ participants over the age of 35 years whose abnormal uterine bleeding is being evaluated via endometrial biopsy. Prospective participants will consent to access the information in their medical records, including access to their pathology report. A subset of participants (n=450) will be invited to self-collect vaginal DNA and microbiome samples using swabs and vaginal pH using a litmus kit for sequencing and analysis. A subset of those who retain their uterus (i.e. are not directed to a hysterectomy per standard clinical management) (n=200+), will be invited to take part in longitudinal monitoring using a wearable fitness tracker (Fitbit) and questionnaires, and an additional vaginal self-collection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EIN/EC BIOPSY RESULT | – | –Vaginal samples sequenced. Participation ends here. |
| EH BIOPSY RESULT | – | –Vaginal samples sequenced. Subset invited to move on to longitudinal monitoring and samples sequenced for 6 additional months. |
| NEGATIVE BIOPSY RESULT | – | –Control for natural and spontaneous changes in vaginal samples sequenced. Random subset selected to move on to longitudinal monitoring and samples sequenced for 6 additional months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study investigators will have 10-15 study gynecologists across British Columbia, Canada, who will be recruiting study participants from patients who are referred to them for an endometrial biopsy due to abnormal uterine bleeding. The investigators aim to recruit ~1000 participants in Study Part A in order to achieve their target sample size of n=50 EIN/EC and n=150 EH. Sequenced participants will be invited to participate in Study Part B/ Longitudinal monitoring and provide additional samples.
Key inclusion criteria (7 listed)
- 40 years and older
- Experiencing unexplained abnormal uterine bleeding (i.e., not from IUD, etc.)
- Have an intact uterus
- Referred for an endometrial biopsy
- Those selected for sequencing (from Part A) and who retained their uterus.
Key exclusion criteria (7 listed)
- Endometrial sampling, pelvic radiation, or vaginal infection (vaginosis, yeast) in the past 3 months
- Started hormone therapy (HRT, birth control, IUD) in the past year (with the exception of tamoxifen)
- Intercourse, vaginal product use, or douching in the past 48 hours
- Same as Study Part A
- EC or EIN, or anyone who is recommended a hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance of cfDNA Mutation Detection for Endometrial Pathology
Time frame: Through study completion, anticipated 1-2 years
Cell-free DNA (cfDNA) extracted from vaginal swabs will be sequenced to identify endometrial cancer-associated mutations. Diagnostic performance will be evaluated by calculating sensitivity, specificity, accuracy, positive predictive value, and negative predictive value for detecting endometrial pathology, using biopsy-confirmed pathology as the reference standard.
Association Between Vaginal Microbiome Profile and Endometrial Pathology
Time frame: Through study completion, anticipated 1-2 years
Vaginal microbiome DNA extracted from swabs will be sequenced and processed into operational taxonomic units (OTUs) using an in-house bioinformatics pipeline. OTUs will be compared across biopsy-confirmed pathology groups and evaluated against previously published microbiome signatures predictive of endometrial cancer.
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 16 Apr 2026.
- Background: PubMed 23935463Pfeiffer RM, Park Y, Kreimer AR, Lacey JV Jr, Pee D, Greenlee RT, Buys SS, Hollenbeck A, Rosner B, Gail MH, Hartge P. Risk prediction for breast, endometrial, and ovarian cancer in white women aged 50 y or older: derivation and validation from population-based cohort studies. PLoS Med. 2013;10(7):e1001492. doi: 10.1371/journal.pmed.1001492. Epub 2013 Jul 30.
- 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.
Aline Talhouk, PhD principal investigator
University of British Columbia
Anna Tinker, MD principal investigator
University of British Columbia
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 University of British Columbia at 1 site in Canada.
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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. 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 Canada. 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?
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 Aline Talhouk, PhD (+1 (604) 875-4111 ext. 21365, a.talhouk@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of cfDNA Mutation Detection for Endometrial Pathology (time frame: Through study completion, anticipated 1-2 years). The study lists 2 primary outcomes in all. 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 NCT06268626, which also lists 1 linked publication.
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 16 Apr 2026.