Ovarian DiseasesEarly Phase 1OCEDPNCT01292733
Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer
A Early Phase 1 study testing Laboratory Tumor Marker Analysis, Transvaginal Ultrasound and Health Status Questionnaire in people with Ovarian Diseases and Ovarian Neoplasms, run by Swedish Medical Center at 1 site in United States.
Trial summary
The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Diseases, Ovarian Neoplasms
- What is being tested?
- Laboratory Tumor Marker Analysis, Transvaginal Ultrasound and Health Status Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2015
- Phase
- Early Phase 1
- 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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must meet one of the following:
- The family contains at least two ovarian or breast cancers in the subject or first or second degree relatives of the subject.
- The subject is of Ashkenazi Jewish ethnicity with one first degree or two second-degree relatives with breast or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer.
- The subject has a male relative with breast cancer diagnosed at any age.
- Probability of carrying a BRCA1/2 mutation given family pedigree of breast and ovarian cancers exceeds 20% (as determined by BRCAPRO 95% posterior probability interval).
Who cannot join
- Prior ovarian cancer or peritoneal carcinomatosis
- A first or second degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation.
- The subject has no ovaries.
- Less than 30 years of age, unless 25-30 with BRCA I or II mutation confirmed
- Currently pregnant
- Currently receiving adjuvant chemotherapy or radiation therapy for cancer (excluding tamoxifen). Patients who are being treated for local disease may enroll 3 months after completion of last treatment (excluding tamoxifen).
- Treatment (excluding tamoxifen) for prior metastatic malignancy within the past five years.
- Intraperitoneal surgery within the last 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Marsha Rivkin Center for Ovarian Cancer Research
Seattle, Washington, 98122
About this study
Official title: Ovarian Cancer Early Detection Screening Program
The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.
Read the detailed description
The program will offer twice yearly CA-125 blood tests and annual transvaginal ultrasounds to monitor women at high risk for ovarian cancer. In addition to the main purpose of providing ovarian cancer screening, the researchers would also like to build a repository of blood specimens for use in ovarian and breast cancer research and to offer genetics counseling sessions to help educate women about risk-reducing options.
- Conditions
- Ovarian Diseases, Ovarian Neoplasms
- Being tested
- Laboratory Tumor Marker Analysis, Transvaginal Ultrasound, Health Status Questionnaire
- Keywords
- Women with increased risk for developing ovarian cancer, Women diagnosed with reproductive cancer, Women with relatives who have had ovarian or breast cancer
- Medical subject headings
- Ovarian Diseases, Ovarian Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Tumor Marker AnalysisOther
Performed every 6 months, these blood samples will be drawn to measure the concentration of CA125 tumor marker. Remaining samples will be stored in a specimen repository for use in future research for ovarian and breast cancer tumor markers.
Transvaginal UltrasoundOther
Performed annually, these pelvic ultrasounds will be used used to look for 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity.
Health Status QuestionnaireOther
Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Cancer Screening | Experimental | CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires Receives: Other: Laboratory Tumor Marker Analysis; Other: Transvaginal Ultrasound; Other: Health Status Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring for elevated levels of tumor marker CA-125 in the blood over time.
Measured: Average expected time of 1 year
Secondary outcomes (2)
Performing transvaginal ultrasounds to look for any abnormalities over time.
Criteria for an abnormal scan include 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity. Volume calculations will determine whether the ovary is enlarged.
Measured: Average expected time of 1 year
Performing health status questionnaires over time
Measured: Average expected time of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Closed per local IRB due to advancements in standard ovarian cancer screening.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, The Marsha Rivkin Center for Ovarian Cancer Research
- Responsible party
- Sponsor
- Investigators
- Pamela Paley, MD, Principal investigator, Swedish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292733
- Sponsor's protocol ID
- IR 4707
- Other IDs
- CRC 08108
- Acronym
- OCEDP
- Status last verified
- Jan 2016
- First submitted
- 30 Nov 2010
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Cancer Early Detection Screening Program
- ClinicalTrials.gov ID
- NCT01292733
- Acronym / sponsor ID
- OCEDP / IR 4707
- Conditions
- Ovarian Diseases, Ovarian Neoplasms
- Keywords
- Women with increased risk for developing ovarian cancer, Women diagnosed with reproductive cancer, Women with relatives who have had ovarian or breast cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed per local IRB due to advancements in standard ovarian cancer screening.
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, The Marsha Rivkin Center for Ovarian Cancer Research
- Study start
- Aug 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Feb 2011 (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.
The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.
Detailed description
The program will offer twice yearly CA-125 blood tests and annual transvaginal ultrasounds to monitor women at high risk for ovarian cancer. In addition to the main purpose of providing ovarian cancer screening, the researchers would also like to build a repository of blood specimens for use in ovarian and breast cancer research and to offer genetics counseling sessions to help educate women about risk-reducing options.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian Cancer Screening | Experimental | Other: Laboratory Tumor Marker Analysis, Other: Transvaginal Ultrasound, Other: Health Status QuestionnaireCA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must meet one of the following:
Key exclusion criteria (8 listed)
- Prior ovarian cancer or peritoneal carcinomatosis
- A first or second degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation.
- The subject has no ovaries.
- Less than 30 years of age, unless 25-30 with BRCA I or II mutation confirmed
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Tumor Marker AnalysisPerformed every 6 months, these blood samples will be drawn to measure the concentration of CA125 tumor marker. Remaining samples will be stored in a specimen repository for use in future research for ovarian and breast cancer tumor markers. | Other | Ovarian Cancer Screening |
| Transvaginal UltrasoundPerformed annually, these pelvic ultrasounds will be used used to look for 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity. | Other | Ovarian Cancer Screening |
| Health Status QuestionnairePerformed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history. | Other | Ovarian Cancer Screening |
Primary outcome
Measuring for elevated levels of tumor marker CA-125 in the blood over time.
Time frame: Average expected time of 1 year
2 secondary outcomes
Performing transvaginal ultrasounds to look for any abnormalities over time.
Time frame: Average expected time of 1 year
Performing health status questionnaires over time
Time frame: Average expected time of 1 year
Results and safety
The study was stopped early (reason given: Closed per local IRB due to advancements in standard ovarian cancer screening.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Marsha Rivkin Center for Ovarian Cancer ResearchLink provided by the sponsor.
Related trials for Ovarian Diseases
Active, not recruitingObservational study
Association Between Polycystic Ovary Syndrome and Sleep Quality: A Questionnaire-Based Study
Sleep Disorder, Polycystic Ovarian Syndrome (PCOS)
RecruitingObservational study
Real-World Study of Mirvetuximab Soravtansine in Adult Participants With Platinum-Resistant FRα-Positive Ovarian, Fallopian Tube, and Peritoneal Cancer
Platinum-Resistant FRα-Positive Ovarian Cancer, Platinum-Resistant FRα-Positive Fallopian Tube Cancer
Recruiting
OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy
Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Pamela Paley, MD principal investigator
Swedish Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Laboratory Tumor Marker Analysis, Transvaginal Ultrasound and Health Status Questionnaire in people with Ovarian Diseases and Ovarian Neoplasms, run by Swedish Medical Center 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Jan 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Closed per local IRB due to advancements in standard ovarian cancer screening.). Results are not available in the source record.
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?
Measuring for elevated levels of tumor marker CA-125 in the blood over time. (time frame: Average expected time of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2016.