Ovarian CancerNCT00879840
Assessment of Screening Modalities for Gynecologic Cancers
An observational study of Ovarian Cancer and Endometrial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Endometrial and ovarian cancers are, respectively, the fourth and eighth most common cancers among women in the United States. Although some routine Pap tests may detect the presence of cancer cells, there are no convincing early detection approaches for either cancer. Read more about this study
- Who is it for?
- Ages 50 to 120 years, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Controls Without Endometrial Cancer
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2009to 16 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with endometrial cancer, ovarian cancer, and women undergoing hysterectomy for benign reasons.
Who may be able to join
- The study will enroll a total of 170 women consented for hysterectomy. One hundred and seventeen (117) will either have 1) suspected ovarian cancer based on clinical impression, cytologic or histologic diagnoses (effusions, Pap tests or other biopsies), or 2) suspected endometrial cancer based on biopsy diagnoses of atypical endometrial hyperplasia (or its equivalent endometrial intraepithelial neoplasia), endometrial intraepithelial carcinoma (i.e. in-situ/ early serous carcinoma) or carcinoma. Fifty-three (53) will be undergoing definitive treatment for benign conditions (uterine fibroids, benign appearing adnexal pathology and normal CA 125, pelvic floor dysfunction not to exceed grade 1 or 2 uterine descensus). Since the analyzed cancers do not occur in children, they will not be included in this study.
Who cannot join
- Surgical candidates for recurrent disease
- Preoperative neoadjuvant chemotherapy or radiotherapy
- History of tubal ligation, salpingitis, or hysterectomy (ovarian cancer patients)
- Control patients who are less than 45 years of age.
- Patients receiving treatment for active endometriosis.
- Cervical stenosis recognized clinically by not accepting the Tao Brush
Show all 9Show fewer
- Endometrial sampling within 5 days of anticipated surgery
- Prior history of endometrial ablation
- Patients with cervical cancer
Trial locations and contacts
1 site in 1 country.
About this study
Background:
- Endometrial and ovarian cancers are, respectively, the fourth and eighth most common cancers among women in the United States. Although some routine Pap tests may detect the presence of cancer cells, there are no convincing early detection approaches for either cancer. Better methods of detection are needed.
- Two possible methods for cancer detection involve samples taken with a tampon or a special kind of brush, called a Tao brush. Researchers would like to know more about how well these methods work.
Read more
Objectives:
- To assess the quality of DNA collected by the tampon and Tao brush sampling methods.
- To detect genetic markers in collected DNA and determine if these markers are related to an individual s cancer status.
Eligibility:
- Women age 45 years and older with confirmed or suspected endometrial or ovarian cancer, who will be having surgery.
- A control group of postmenopausal women having surgery for benign gynecological conditions will be included.
Design:
- Shortly before hysterectomy or more extensive procedures to treat either cancer or the benign condition:
- A tampon will be inserted into the vagina to collect cell samples, and removed after 30 minutes.
- After the tampon is removed, the cervix will be swabbed with the Tao brush to collect cell samples.
- Following the hysterectomy, samples of healthy and cancerous tissue will be taken, and tested by researchers.
Read the detailed description
Background:
Currently, there are no convincing early detection approaches for endometrial and ovarian cancers. Although it is well established that some endometrial and ovarian tumors shed cytologically recognizable cells in routinely prepared Pap tests, it is clear that this approach rarely detects occult tumors. Accordingly, efforts to develop means of collecting biological samples that have high patient acceptability, good sensitivity for detecting early disease, and excellent specificity are needed.
Objectives:
In this project, we want to assess the feasibility of using alternative sampling techniques in combination with molecular assays to detect endometrial and ovarian cancers. We will compare sampling using a Tampon and a sheathed endometrial brush, the Tao brush. We want to assess the quality of DNA extracted from the different samplers. We will assess the correlations between methylation of somatic DNA for a selected marker panel and cancer status.
Eligibility:
We wish to include 117 women age 45 years and older with suspected endometrial cancer, or ovarian cancer, and 53 age-matched (plus/minus 5 years) controls without malignancy, all of whom are referred to surgery at the Mayo clinic.
Design:
We plan to conduct a pilot study of women with confirmed or suspected endometrial cancer, or ovarian cancer, and women treated for benign conditions. DNA will be extracted from samples collected using a vaginal Tampon and an endometrial brushing using an FDA approved device (Tao brush) prior to surgery. A panel of methylation markers will be analyzed from samples yielding sufficient DNA. The results of the methylation analysis will be compared to the final histology for all patients in the study. We will set the detection of methylation at one or more loci in 50% of women in each arm as a technical success.
- Conditions
- Ovarian Cancer, Endometrial Cancer, Controls Without Endometrial Cancer, Controls Without Ovarian Cancer
- Keywords
- Screening, Modalities, Gynecological Cancers
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms
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 |
|---|---|---|
| Females | With endometrial cancer, ovarian cancer, and women undergoing hysterectomy for benign reasons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Cancer, ovarian cancer
Histologically confirmed endometrial or ovarian cancer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study start9 Apr 2009
- Primary completion2 Sep 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 only
- Time perspective
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nicolas Wentzensen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879840
- Sponsor's protocol ID
- 999909121
- Other IDs
- 09-C-N121
- Status last verified
- Nov 2020
- First submitted
- 10 Apr 2009
- Last updated
- 17 Nov 2020
- Results posted
- No
Publications
Ries LA. Ovarian cancer. Survival and treatment differences by age. Cancer. 1993 Jan 15;71(2 Suppl):524-9. doi: 10.1002/cncr.2820710206.
PubMed 8420672Buys SS, Partridge E, Greene MH, Prorok PC, Reding D, Riley TL, Hartge P, Fagerstrom RM, Ragard LR, Chia D, Izmirlian G, Fouad M, Johnson CC, Gohagan JK; PLCO Project Team. Ovarian cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial: findings from the initial screen of a randomized trial. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9. doi: 10.1016/j.ajog.2005.05.005.
PubMed 16260202Vine MF, Ness RB, Calingaert B, Schildkraut JM, Berchuck A. Types and duration of symptoms prior to diagnosis of invasive or borderline ovarian tumor. Gynecol Oncol. 2001 Dec;83(3):466-71. doi: 10.1006/gyno.2001.6411.
PubMed 11733956
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Screening Modalities for Gynecologic Cancers
- ClinicalTrials.gov ID
- NCT00879840
- Acronym / sponsor ID
- 999909121
- Conditions
- Ovarian Cancer, Endometrial Cancer, Controls Without Endometrial Cancer, Controls Without Ovarian Cancer
- Keywords
- Screening, Modalities, Gynecological Cancers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Apr 2009 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 13 Apr 2009 (estimated)
- 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.
Background:
- Endometrial and ovarian cancers are, respectively, the fourth and eighth most common cancers among women in the United States. Although some routine Pap tests may detect the presence of cancer cells, there are no convincing early detection approaches for either cancer. Better methods of detection are needed.
- Two possible methods for cancer detection involve samples taken with a tampon or a special kind of brush, called a Tao brush. Researchers would like to know more about how well these methods work.
Objectives:
- To assess the quality of DNA collected by the tampon and Tao brush sampling methods.
- To detect genetic markers in collected DNA and determine if these markers are related to an individual s cancer status.
Eligibility:
- Women age 45 years and older with confirmed or suspected endometrial or ovarian cancer, who will be having surgery.
- A control group of postmenopausal women having surgery for benign gynecological conditions will be included.
Design:
- Shortly before hysterectomy or more extensive procedures to treat either cancer or the benign condition:
- A tampon will be inserted into the vagina to collect cell samples, and removed after 30 minutes.
- After the tampon is removed, the cervix will be swabbed with the Tao brush to collect cell samples.
- Following the hysterectomy, samples of healthy and cancerous tissue will be taken, and tested by researchers.
Detailed description
Background:
Currently, there are no convincing early detection approaches for endometrial and ovarian cancers. Although it is well established that some endometrial and ovarian tumors shed cytologically recognizable cells in routinely prepared Pap tests, it is clear that this approach rarely detects occult tumors. Accordingly, efforts to develop means of collecting biological samples that have high patient acceptability, good sensitivity for detecting early disease, and excellent specificity are needed.
Objectives:
In this project, we want to assess the feasibility of using alternative sampling techniques in combination with molecular assays to detect endometrial and ovarian cancers. We will compare sampling using a Tampon and a sheathed endometrial brush, the Tao brush. We want to assess the quality of DNA extracted from the different samplers. We will assess the correlations between methylation of somatic DNA for a selected marker panel and cancer status.
Eligibility:
We wish to include 117 women age 45 years and older with suspected endometrial cancer, or ovarian cancer, and 53 age-matched (plus/minus 5 years) controls without malignancy, all of whom are referred to surgery at the Mayo clinic.
Design:
We plan to conduct a pilot study of women with confirmed or suspected endometrial cancer, or ovarian cancer, and women treated for benign conditions. DNA will be extracted from samples collected using a vaginal Tampon and an endometrial brushing using an FDA approved device (Tao brush) prior to surgery. A panel of methylation markers will be analyzed from samples yielding sufficient DNA. The results of the methylation analysis will be compared to the final histology for all patients in the study. We will set the detection of methylation at one or more loci in 50% of women in each arm as a technical success.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females | – | –With endometrial cancer, ovarian cancer, and women undergoing hysterectomy for benign reasons. |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with endometrial cancer, ovarian cancer, and women undergoing hysterectomy for benign reasons.
Key inclusion criteria (1 listed)
- The study will enroll a total of 170 women consented for hysterectomy. One hundred and seventeen (117) will either have 1) suspected ovarian cancer based on clinical impression, cytologic or histologic diagnoses (effusions, Pap tests or other biopsies), or 2) suspected endometrial cancer based on biopsy diagnoses of atypical endometrial hyperplasia (or its equivalent endometrial intraepithelial neoplasia), endometrial intraepithelial carcinoma (i.e. in-situ/ early serous carcinoma) or carcinoma. Fifty-three (53) will be undergoing definitive treatment for benign conditions (uterine fibroids, benign appearing adnexal pathology and normal CA 125, pelvic floor dysfunction not to exceed grade 1 or 2 uterine descensus). Since the analyzed cancers do not occur in children, they will not be included in this study.
Key exclusion criteria (9 listed)
- Surgical candidates for recurrent disease
- Preoperative neoadjuvant chemotherapy or radiotherapy
- History of tubal ligation, salpingitis, or hysterectomy (ovarian cancer patients)
- Control patients who are less than 45 years of age.
- Patients receiving treatment for active endometriosis.
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
Endometrial Cancer, ovarian cancer
Time frame: 1 year
Histologically confirmed endometrial or ovarian cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Background: PubMed 8420672Ries LA. Ovarian cancer. Survival and treatment differences by age. Cancer. 1993 Jan 15;71(2 Suppl):524-9. doi: 10.1002/cncr.2820710206.
- Background: PubMed 16260202Buys SS, Partridge E, Greene MH, Prorok PC, Reding D, Riley TL, Hartge P, Fagerstrom RM, Ragard LR, Chia D, Izmirlian G, Fouad M, Johnson CC, Gohagan JK; PLCO Project Team. Ovarian cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial: findings from the initial screen of a randomized trial. Am J Obstet Gynecol. 2005 Nov;193(5):1630-9. doi: 10.1016/j.ajog.2005.05.005.
- Background: PubMed 11733956Vine MF, Ness RB, Calingaert B, Schildkraut JM, Berchuck A. Types and duration of symptoms prior to diagnosis of invasive or borderline ovarian tumor. Gynecol Oncol. 2001 Dec;83(3):466-71. doi: 10.1006/gyno.2001.6411.
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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. This study is not recruiting at the moment.
Nicolas Wentzensen, M.D. principal investigator
National Cancer Institute (NCI)
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 Ovarian Cancer and Endometrial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 17 Nov 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Cancer, ovarian cancer (time frame: 1 year). 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 NCT00879840, which also lists 3 linked publications.
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 17 Nov 2020.