Printed from Voxsanity (voxsanity.com.au) — NCT05051722 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Ovarian Cancer Trial, Recruiting
NCT05051722
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
This trial has multiple groups (called cohorts). Each group has its own criteria.
Group 1 – People with abnormal uterine bleeding:
Who might be able to join this group:
- People aged 45 or older who have abnormal uterine bleeding or bleeding after menopause
- People aged 18 to 44 who have abnormal uterine bleeding AND at least one of the following: a BMI of 30 or higher, a condition called polycystic ovary syndrome (PCOS), or current use of a medication called Tamoxifen
Who may not be able to join this group:
- People who have previously had their uterus removed (hysterectomy)
- People who are currently known to be pregnant
- People who have had radiation therapy to the pelvis or vagina at any point in the past
- People who have had any cancer (other than a common type of skin cancer called basal cell cancer) within the past 5 years
- People who have received chemotherapy within the past 5 years
- People with a confirmed diagnosis of cancer or pre-cancerous changes in the cervix, vagina, or vulva
- People with a confirmed diagnosis of uterine (endometrial) cancer or a condition called endometrial hyperplasia
- People with a confirmed diagnosis of a non-cancerous uterine polyp
- People who have had a uterine tissue sample taken in the past month that came back showing normal tissue
Group 2 – People with confirmed uterine (endometrial) cancer or pre-cancerous uterine conditions who are planning surgery:
Who might be able to join this group:
- People aged 18 or older with a biopsy-confirmed diagnosis of endometrial cancer (any type, including a type called uterine carcinosarcoma) who are planning to have surgery (which may include hysterectomy, a procedure called D&C, or surgical removal through a camera procedure called hysteroscopy)
- People aged 18 or older with a biopsy showing a pre-cancerous uterine condition (called AEH or EIN) who are planning to have surgery (which may include hysterectomy, D&C, or hysteroscopic resection)
Who may not be able to join this group:
- People having surgery for endometrial cancer that has come back or spread to other parts of the body
- People who have already received chemotherapy or radiation therapy as treatment before surgery for their current endometrial cancer diagnosis
- People who have previously had their uterus removed (hysterectomy)
- People who are currently known to be pregnant
- People with a confirmed past or current diagnosis of cervical cancer
- People with a confirmed diagnosis of pre-cancerous changes in the cervix (cervical dysplasia)
- People who have had radiation therapy to the pelvis or vagina at any point in the past
- People who have had any cancer (other than basal cell skin cancer) within the past 5 years
- People who have received chemotherapy within the past 5 years
- People who have already had a procedure specifically intended to completely remove the tissue being studied
Group 3 – People with abnormal cervical results or a cervical mass:
Who might be able to join this group:
- People aged 18 or older who still have a cervix, and who have a current abnormal cervical Pap test result and are being referred for a closer examination called colposcopy
- People aged 18 or older who still have a cervix, and in whom a cervical mass has been found during a physical examination and who are being referred for a cervical biopsy
- People aged 18 or older who still have a cervix and are scheduled for a planned surgical procedure to remove or sample cervical tissue (such as a cold knife cone, a procedure called LEEP, or hysterectomy) due to an abnormal Pap test, pre-cancerous cervical changes, a cervical mass, or a biopsy-confirmed cervical cancer
Who may not be able to join this group:
- People who have had radiation therapy to the pelvis or vagina at any point in the past
- People who have previously had a hysterectomy in which the cervix was removed
- People who are currently known to be pregnant
- People whose cervical mass has been confirmed by biopsy to be uterine cancer or a cancer that has spread from another part of the body
- People who have had any cancer (other than basal cell skin cancer) within the past 5 years
- People who have received chemotherapy within the past 5 years
- People attending colposcopy only as a routine follow-up after previous treatment, with no current abnormal Pap result or cervical mass
- People who have already had a procedure specifically intended to completely remove the tissue being studied during this current episode of care
Group 4 – People aged 45 or older having surgery for non-cancerous gynaecological conditions:
Who might be able to join this group:
- People aged 45 or older who are having a hysterectomy for a confirmed or clinically expected non-cancerous condition such as fibroids, endometriosis, adenomyosis, or non-cancerous uterine polyps
- People aged 45 or older having any gynaecological surgery in which a non-cancerous diagnosis of fibroids, endometriosis, adenomyosis, or a non-cancerous uterine polyp is expected to be confirmed
Who may not be able to join this group:
- People who have had a uterine biopsy or an internal camera examination of the uterus (office hysteroscopy) within the 2 weeks before their planned surgery
- People who have had any surgery within the past 3 months
- People who have previously had their uterus removed (hysterectomy)
- People who are currently known to be pregnant
- People with a confirmed past or current diagnosis of gynaecological cancer
- People with a confirmed diagnosis of a pre-cancerous uterine condition (AEH/EIN) or pre-cancerous changes in the cervix, vagina, or vulva
- People who have had radiation therapy to the pelvis or vagina at any point in the past
- People who have had any cancer (other than basal cell skin cancer) within the past 5 years
- People who have received chemotherapy within the past 5 years
- People having a hysterectomy only for a condition called prolapse, without also having a known or expected non-cancerous uterine condition such as fibroids, endometriosis, polyps, or adenomyosis
- People who have already had a procedure specifically intended to completely remove the tissue being studied during this current episode of care
Group 5 – People attending a routine gynaecological wellness check:
Who might be able to join this group:
- People aged 45 or older who still have a uterus, are attending a routine gynaecological wellness visit (with or without a Pap test), and have had no changes in medical conditions, new diagnoses, or new medications in the past 6 months
Who may not be able to join this group:
- People who have had a Pap test or cervical biopsy within the past month
- People who have had a uterine biopsy or an internal camera examination of the uterus within the past month
- People who have had any surgery within the past 3 months
- People who have previously had their uterus removed (hysterectomy)
- People who are currently known to be pregnant
- People with a confirmed past or current diagnosis of gynaecological cancer
- People with a confirmed diagnosis of a pre-cancerous uterine condition (AEH/EIN) or pre-cancerous changes in the cervix, vagina, or vulva
- People who have had radiation therapy to the pelvis or vagina at any point in the past
- People who have had any cancer (other than basal cell skin cancer) within the past 5 years
- People who have received chemotherapy within the past 5 years
- People who meet the criteria for any of the other groups in this study
Group 6 – Post-menopausal people with a suspected ovarian mass or early-stage ovarian cancer:
Who might be able to join this group:
- People aged 50 or older who are post-menopausal, have at least one ovary, have been diagnosed with or are suspected to have an ovarian mass or early-stage ovarian cancer (including fallopian tube cancer), and are planning to have surgery for the mass
- For a specific fluid sample collection method: people who also have a uterus, cervix, and at least one intact fallopian tube that has not been tied or blocked previously
Who may not be able to join this group:
- People with any current or previous cancer diagnosis (other than common non-gynaecological skin cancers — basal cell or squamous cell skin cancer)
- People who have received chemotherapy for cancer within the past 5 years
- People suspected of having advanced-stage ovarian cancer (Stage III or IV) at the time of presentation, if this is known before samples are collected
- People being considered for surgery due to ovarian cancer that has come back
- People who have had radiation therapy to the pelvis or vagina at any point in the past
- People with a known current diagnosis of uterine cancer or uterine hyperplasia
- People with a known current diagnosis of pre-cancerous changes in the cervix, vagina, or vulva
Group 7 – People newly diagnosed with ovarian, fallopian tube, or primary peritoneal cancer:
Who might be able to join this group:
- People aged 18 or older with a clinically probable diagnosis of ovarian, fallopian tube, or primary peritoneal cancer, based on findings such as imaging results, elevated cancer marker levels (CA125), fluid in the abdomen (ascites), or a biopsy result consistent with this type of cancer
- People newly diagnosed with this type of cancer who have not yet received any treatment before surgery
- People with at least one intact ovary
- For a specific fluid sample collection method: people who also have a uterus, cervix, and at least one intact fallopian tube that has not been tied or blocked previously
Who may not be able to join this group:
- People whose ovarian, fallopian tube, or peritoneal cancer has come back after previous treatment
- People with any current or previous cancer diagnosis (other than common non-gynaecological skin cancers — basal cell or squamous cell skin cancer) within the past 5 years
- People who have received chemotherapy for cancer within the past 5 years
- People who have had radiation therapy to the pelvis or vagina at any point in the past
- People with a known current diagnosis of uterine cancer or uterine hyperplasia
- People with a known current diagnosis of pre-cancerous changes in the cervix, vagina, or vulva
- People who are currently known to be pregnant
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
Contact this trial
Principal Investigator: Jamie N. Bakkum-Gamez, M.D., Mayo Clinic
Phone: 507-293-1487
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
3 August 2021
Est. completion
31 December 2026
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Develop predictive models from a panel of EC-specific MDMs and validate their performance in identifying underlying EC and AEH within vaginal fluid in a larger, more diverse cohort.; Develop predictive models from a panel of OC-specific MDMs and validate their performance in identifying underlying OC within vaginal fluid and plasma in a larger, more diverse cohort.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.