High Grade Ovarian Serous Adenocarcinoma, 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
Conditions
Brief summary
The goal of this project is to develop a minimally invasive test to detect ovarian cancer, by searching for mutations from the tumor in samples obtained from the cervix (Pap smears), and from the uterus (uterine lavage) in participants with advanced ovarian cancer and in participants with increased risk of ovarian cancer due to inherited mutations, such as BRCA or BRCA2 (among others). Pap smear and uterine lavage samples will be collected while the participant is under anesthesia for planned debulking surgery. A novel, highly sensitive and accurate technique, Crispr-Duplex sequencing, will be used to detect tumor associated mutations in TP53 (the most commonly mutated gene in ovarian cancer) within these samples. These results will be compared to sequencing results in the tumor itself for comparison, and Pap and uterine lavage will be compared to each other to determine the optimal test. Ultimately, the goal is to use the results of this study to plan a larger study including women without cancer who are at either increased risk or normal risk of ovarian cancer, for use in early detection.
Detailed description
OUTLINE: Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing.
Interventions
Sponsors
Minnesota Ovarian Cancer Alliance
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* With suspected advanced ovarian cancer or genetic predisposition to malignant neoplasm of the ovary * Planned surgery * Have a uterus and no history of tubal occlusion
Exclusion criteria
* Unable to speak English * Unable to provide informed consent * Prior hysterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage | A single point in time after sample collection, no follow-up of participants is done | In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample) Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing.
Biospecimen Collection: Undergo collection of tumor sample and blood draw
Laboratory Biomarker Analysis: Correlative studies
Lavage: Undergo uterine lavage
Pap Smear: Undergo pap smear | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unable to collect sample | 5 |
Baseline characteristics
| Characteristic | Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
Primary
20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage
In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer.
Time frame: A single point in time after sample collection, no follow-up of participants is done
Population: We were able to enroll 20 participants who ended up having ovarian cancer. We recruited less than expected due to the COVID19 pandemic and increased use of neoadjuvant chemotherapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic (Pap Smear, Uterine Lavage, Tumor Sample) | 20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage | 13 Participants |