Trial NCT04794322
Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer
- Phase
- Not given
- Sponsor
- Massachusetts General Hospital
- Conditions
- Ovarian Neoplasms; Ovarian Epithelial Carcinoma; Fallopian Tube Neoplasms; High Grade Ovarian Serous Adenocarcinoma; Stage I Ovarian Cancer; Stage II Ovarian Cancer; Stage III Ovarian Cancer AJCC v8; Stage IIIA Ovarian Cancer AJCC v8; Stage IIIA1 Ovarian Cancer AJCC v8; Stage IIIA2 Ovarian Cancer AJCC v8; Stage IIIB Ovarian Cancer AJCC v8; Stage IIIC Ovarian Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IVA Ovarian Cancer AJCC v8; Stage IVB Ovarian Cancer AJCC v8
- Ages
- 30+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Has intact uterus (no history of uterine ablation, tubal ligation or bilateral salpingectomy)
* Cohort 1 (n=200 participants): Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian/fallopian tube cancer
* Cohort 2 (n=50 participants): Known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing salpingo-oophorectomy
Exclusion Criteria:
* Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer
* Inability to provide informed consent
* Age less than 30 yearsAge
* Inability to obtain the minimum amount of blood
* Inability to obtain the minimum amount of uterine lavage sample
* At risk if blood were drawn (e.g. hemophilia, serious anemia- Hb less than 8.0 gm/dL)
* Prior history of known ovarian or endometrial cancerPrior malignancy
* Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin
* History of untreated high-grade cervical dysplasia (CIN3)
* History of treated high grade cervical dysplasia (CIN3) with a cytologically abnormal pap smear within the past year. If there is no post treatment Pap smear in the medical record, perform a Pap smear prior to the day of surgery. If this Pap smear is abnormal, the participant is ineligible.
* Currently pregnantPregnancy
* Known Lynch syndrome
Restrictions found (3)
- AgeOutrightexclusionShow in the text
- PregnancyOutrightexclusionShow in the text
- Prior malignancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County