Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | November 16, 2018 |
| End Date: | September 15, 2019 |
Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas
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 women with advanced ovarian cancer. The investigators
plan a pilot study of 25 women with advanced ovarian cancer. Pap smear and uterine lavage
samples will be collected while the woman 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.
searching for mutations from the tumor in samples obtained from the cervix (Pap smears), and
from the uterus (uterine lavage) in women with advanced ovarian cancer. The investigators
plan a pilot study of 25 women with advanced ovarian cancer. Pap smear and uterine lavage
samples will be collected while the woman 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.
PRIMARY OBJECTIVES:
I. To collect samples from at least 25 women with advanced, high-grade serous ovarian
carcinoma (OC), including Papanicolaou (pap) smears, uterine lavage, and a tumor sample.
II. To test the deoxyribonucleic acid (DNA) from pap smears and uterine lavage samples for
tumor-derived TP53 mutations, using the new technology of Crispr-Duplex sequencing.
III. Determine the sensitivity and specificity of Pap smear or uterine lavage in detection of
tumor-derived TP53 mutations.
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.
I. To collect samples from at least 25 women with advanced, high-grade serous ovarian
carcinoma (OC), including Papanicolaou (pap) smears, uterine lavage, and a tumor sample.
II. To test the deoxyribonucleic acid (DNA) from pap smears and uterine lavage samples for
tumor-derived TP53 mutations, using the new technology of Crispr-Duplex sequencing.
III. Determine the sensitivity and specificity of Pap smear or uterine lavage in detection of
tumor-derived TP53 mutations.
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.
Inclusion Criteria:
- With suspected advanced ovarian cancer
- Planned surgery
- Have a uterus and no history of tubal occlusion
Exclusion Criteria:
- Unable to speak English
- Unable to provide informed consent
- Prior hysterectomy
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Barbara S. Norquist
Phone: 206-616-1620
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