Ovarian CancerNCT01787656
A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus
An observational study of Ovarian Cancer, run by University of South Alabama at 1 site in United States.
Trial summary
Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival are low. There is a current belief that this cancer starts in the fallopian tubes and progresses towards the ovaries, spreading to the cells on the surface. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 438 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with an adenxal mass or suspicion of ovarian, fallopian tube, or primary peritoneal cancer
Who may be able to join
- Must be fully consented to the collection of the samples in writing (completed consent forms).
- Age Criteria: Women age 50 and older who are post menopausal (defined as 12 months past last menstrual period).
- Must have: Diagnosis of an adnexal mass or a suspicion of ovarian cancer, or a suspected fallopian tube or primary peritoneal cancer.
- Must have a uterus and cervix.
- Surgery for the adnexal mass must be anticipated. (Only patients with an adnexal mass requiring surgery will be eligible).
Who cannot join
- Any subject who has a condition that would increase the risk associated with the standard sampling procedures (Such as a pap smear, or cotton swab in vagina)
- Prior hysterectomy.
- Absence of adnexal mass.
- Primary diagnosis of a cancer other than ovarian, primary peritoneal or fallopian tube.
- Patients with grossly visible cervical cancer.
- Previous/recent treatment for any invasive gynecologic cancer.
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- Recent chemotherapy within the prior 2 years. (recent neoadjuvant chemotherapy for ovarian cancer would exclude the patient from participation).
- Cervical conization within the prior 6 months.
- History of Radiation therapy to the pelvis, vagina or cervix.
- Obvious advanced stage cancer (Stage III or IV) on presentation, if known prior to specimen collection.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604
About this study
Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival are low. There is a current belief that this cancer starts in the fallopian tubes and progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian tubes and the uterus, there is a constant flow of mucus which has only one exit through the cervix and out the vagina. Proteins that are generated within the entire female reproductive system are trapped into this viscous fluid and eventually released as waste. When a routine PAP test is performed, a sample of this mucus is collected along with any cells, and preserved in the PAP fluid. The fluid is currently discarded but contains a protein profile showing of the status of the cells in the female reproductive system. We have examined this fluid and found that it contains unique peptides/proteins that provide a diagnosis of ovarian cancer when compared against healthy controls. These markers will be initially refined using the comparison of ovarian cancer patients against those with benign adnexal masses that entered the clinic during the same time period.
In this Phase II biomarker validation study we will further refine and validate these biomarkers using a new collection of samples from at least 200 ovarian cancer cases with epithelial ovarian cancer (endometroid and papillary serous histology, most common) and comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter the clinics during the same time period. Patient samples will be collected on their first visit to the gynecologic oncologist at a number of collaborating clinics. Final processing of all of the samples will be performed within the proteomics research facilities of the Mitchell Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry) based on the refined set of makers statistically selected within the first aim. Biomarkers validated within this study will be compared with the well accepted CA-125 data for the patients. The research involves a three year validation and may allow detection of this cancer at a very early stage when the survival is as high as 90%. One aim examines a self-taken test that could allow its use in medically underrepresented and rural areas.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Discovery of biomarkers that allow for the early detection of ovarian cancer
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Collaborators
- ProHealth Care, Inc, Women's Cancer Care, University of Tennessee Cancer Institute, Arizona Oncology Associates, Sarasota Memorial Hospital, Florida Hospital Cancer Institute, Crescent City Physicians, Inc., Sanford USD Medical Center, Monongalia General Hospital, Ochsner Health System, Sacred Heart Health System, Tennessee Valley Gynecologic Oncology, Washington University School of Medicine, Augusta University, Tulane University Health Sciences Center, Cancer Center of South Florida, Mayo Clinic, Marshall University, Indiana University, University of Arizona, St. Luke's Hospital and Health Network, Pennsylvania, Mercy Medical Center
- Responsible party
- Sponsor
- Investigators
- Michael A Finan, PhD, Principal investigator, University of South Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787656
- Sponsor's protocol ID
- USA-MCI GON-1.01
- Status last verified
- Sep 2020
- First submitted
- 6 Feb 2013
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Method of Screening for Ovarian Cancer Using Gynecologic Fluids and Mucus
- ClinicalTrials.gov ID
- NCT01787656
- Acronym / sponsor ID
- USA-MCI GON-1.01
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Collaborators
- ProHealth Care, Inc, Women's Cancer Care, University of Tennessee Cancer Institute, Arizona Oncology Associates, Sarasota Memorial Hospital, Florida Hospital Cancer Institute, Crescent City Physicians, Inc., Sanford USD Medical Center, Monongalia General Hospital, Ochsner Health System, Sacred Heart Health System, Tennessee Valley Gynecologic Oncology, Washington University School of Medicine, Augusta University, Tulane University Health Sciences Center, Cancer Center of South Florida, Mayo Clinic, Marshall University, Indiana University, University of Arizona, St. Luke's Hospital and Health Network, Pennsylvania, Mercy Medical Center
- Study start
- Jan 2013
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 8 Feb 2013 (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.
Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival are low. There is a current belief that this cancer starts in the fallopian tubes and progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian tubes and the uterus, there is a constant flow of mucus which has only one exit through the cervix and out the vagina. Proteins that are generated within the entire female reproductive system are trapped into this viscous fluid and eventually released as waste. When a routine PAP test is performed, a sample of this mucus is collected along with any cells, and preserved in the PAP fluid. The fluid is currently discarded but contains a protein profile showing of the status of the cells in the female reproductive system. We have examined this fluid and found that it contains unique peptides/proteins that provide a diagnosis of ovarian cancer when compared against healthy controls. These markers will be initially refined using the comparison of ovarian cancer patients against those with benign adnexal masses that entered the clinic during the same time period.
In this Phase II biomarker validation study we will further refine and validate these biomarkers using a new collection of samples from at least 200 ovarian cancer cases with epithelial ovarian cancer (endometroid and papillary serous histology, most common) and comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter the clinics during the same time period. Patient samples will be collected on their first visit to the gynecologic oncologist at a number of collaborating clinics. Final processing of all of the samples will be performed within the proteomics research facilities of the Mitchell Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry) based on the refined set of makers statistically selected within the first aim. Biomarkers validated within this study will be compared with the well accepted CA-125 data for the patients. The research involves a three year validation and may allow detection of this cancer at a very early stage when the survival is as high as 90%. One aim examines a self-taken test that could allow its use in medically underrepresented and rural areas.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with an adenxal mass or suspicion of ovarian, fallopian tube, or primary peritoneal cancer
Key inclusion criteria (5 listed)
- Must be fully consented to the collection of the samples in writing (completed consent forms).
- Age Criteria: Women age 50 and older who are post menopausal (defined as 12 months past last menstrual period).
- Must have: Diagnosis of an adnexal mass or a suspicion of ovarian cancer, or a suspected fallopian tube or primary peritoneal cancer.
- Must have a uterus and cervix.
- Surgery for the adnexal mass must be anticipated. (Only patients with an adnexal mass requiring surgery will be eligible).
Key exclusion criteria (10 listed)
- Any subject who has a condition that would increase the risk associated with the standard sampling procedures (Such as a pap smear, or cotton swab in vagina)
- Prior hysterectomy.
- Absence of adnexal mass.
- Primary diagnosis of a cancer other than ovarian, primary peritoneal or fallopian tube.
- Patients with grossly visible cervical cancer.
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
Discovery of biomarkers that allow for the early detection of ovarian cancer
Time frame: 3 years
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 Sep 2020.
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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.
Michael A Finan, PhD principal investigator
University of South Alabama
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, run by University of South Alabama 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 10 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 Sep 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?
Discovery of biomarkers that allow for the early detection of ovarian cancer (time frame: 3 years). 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 17 Sep 2020.