Ovarian CancersncRNANCT01187602
Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer
An observational study of Ovarian Cancer, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to create new tests to identify biomarkers for ovarian cancer so that a screening test can be developed. For patients who have a diagnosis of ovarian Cancer, researchers will use blood samples before and after treatment to see if disease status can be determined by measuring the amount of… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jun 2015
- 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 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women in Gynecologic clinics
Who may be able to join
- Undergoing medical care at UVA
- Up to date breast cancer screening
- Subjects must fall into one of the following groups:
- Women at increased risk of ovarian cancer based on family history, personal history, or genetic factors defined as either BRCA1 or BRCA2 mutations who still retain both fallopian tubes and both ovaries.
- Women at average risk for ovarian cancer
- Women with known/suspected or recurrent ovarian cancer who are undergoing evaluation and/or treatment at UVA Cancer Center
Who cannot join
- Subjects with increased risk for ovarian cancer may not have a history of prior malignancy within the last 10 years excluding cervical carcinoma in situ or basal cell carcinoma
- Pregnancy (self reported)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Heather Lothamer, MSN, 434-924-9924, hll5y@virginia.edu
Susan Modesitt, MD, 434-243-5197
About this study
Official title: A Pilot Study of Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer
The purpose of this study is to create new tests to identify biomarkers for ovarian cancer so that a screening test can be developed. For patients who have a diagnosis of ovarian Cancer, researchers will use blood samples before and after treatment to see if disease status can be determined by measuring the amount of biomarker.
Read the detailed description
Epithelial ovarian cancer is the most lethal female reproductive malignancy, mainly because 80% of tumors have metastasized beyond the ovary at the time of diagnosis. Screening efforts aimed at improved identification of early stage disease have been largely unsuccessful, because of ovarian cancer's propensity for early spread. Our hypothesis is that this obstacle can be circumvented by identifying biomarkers for the precancerous stage of this disease. Since this pre-cancerous stage is currently undetectable, we instead propose to look for biomarkers in women at very high risk for developing ovarian cancer due to genetic mutations. We hypothesize that identification of markers for genetic predisposition to ovarian cancer will also be informative for detection of biological changes that over time lead to sporadic cancers. Given their increasingly recognized role in states of normal and abnormal growth and differentiation, we hypothesize that short non-coding RNAs (sncRNAs) hold significant promise as biomarkers of ovarian cancer predisposition. We will test these hypotheses in two aims. First, we will identify biomarkers for hereditary ovarian cancer risk by comparing serum-derived sncRNAs in women with and without hereditary risk for ovarian cancer. In the second aim we will define serum-derived sncRNAs correlates of ovarian cancer disease status. We will compare sera from ovarian cancer patients at times of highest and lowest disease burden to those of control, cancer-free subjects. Each aim will provide independent, novel, and important information for future investigations. The sncRNAs found to be differentially expressed in both aims will be prioritized for future validation in women under clinical surveillance for hereditary risk of ovarian cancer.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian 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 |
|---|---|---|
| Women at average risk for ovarian cancer | Women at average risk for ovarian cancer (no first degree relatives with breast or ovarian cancer) undergoing gynecologic evaluation at UVA for non-malignant or routine indications. | |
| Women with ovarian cancer | Women with known or suspected ovarian cancer who are undergoing evaluation and/or treatment at UVA Cancer Center | |
| Increased risk for ovarian cancer | Women at increased risk of ovarian cancer based on family history, personal history, or genetic factors defined as either BRCA1 or BRCA2 mutations who still retain both fallopian tubes and both ovaries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defining sncRNA alterations associated with hereditary predisposition to ovarian cancer
Serum samples will be collected from patients with known BRCA mutations. As a control, we will recruit age-matched women undergoing gynecologic evaluation for benign disease without any personal or family history of cancer. The normal and BRCA mutation groups will be pooled for deep sequencing. Pooled sample short RNAs will be cloned and subjected to deep sequencing and bioinformatic analysis. Validation of 5-10 differentially expressed sncRNAs is performed by quantitative RT-PCR and Northern blots on individual control and high risk samples.
Measured: 24 months
Identification of serum derived sncRNA biomarkers that correlate with disease burden in ovarian cancer.
In this aim pre- and post-remission samples from twenty women with stage III-IV ovarian cancer will be compared to twenty samples from control cancer-free subjects. Methods used will be essentially identical to those described above however, given the opportunity to use each patient as her own control and thus minimized confounders we believe deep sequencing of samples individually will provide better quality data and more robust statistical comparison.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
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.
- More trials run by University of VirginiaThe 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-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Modesitt, MD, University of Virginia
- Investigators
- Susan Modesitt, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187602
- Sponsor's protocol ID
- 15099
- Acronym
- sncRNA
- Status last verified
- Dec 2014
- First submitted
- 22 Aug 2010
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01187602
- Acronym / sponsor ID
- sncRNA / 15099
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 24 Aug 2010 (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 purpose of this study is to create new tests to identify biomarkers for ovarian cancer so that a screening test can be developed. For patients who have a diagnosis of ovarian Cancer, researchers will use blood samples before and after treatment to see if disease status can be determined by measuring the amount of biomarker.
Detailed description
Epithelial ovarian cancer is the most lethal female reproductive malignancy, mainly because 80% of tumors have metastasized beyond the ovary at the time of diagnosis. Screening efforts aimed at improved identification of early stage disease have been largely unsuccessful, because of ovarian cancer's propensity for early spread. Our hypothesis is that this obstacle can be circumvented by identifying biomarkers for the precancerous stage of this disease. Since this pre-cancerous stage is currently undetectable, we instead propose to look for biomarkers in women at very high risk for developing ovarian cancer due to genetic mutations. We hypothesize that identification of markers for genetic predisposition to ovarian cancer will also be informative for detection of biological changes that over time lead to sporadic cancers. Given their increasingly recognized role in states of normal and abnormal growth and differentiation, we hypothesize that short non-coding RNAs (sncRNAs) hold significant promise as biomarkers of ovarian cancer predisposition. We will test these hypotheses in two aims. First, we will identify biomarkers for hereditary ovarian cancer risk by comparing serum-derived sncRNAs in women with and without hereditary risk for ovarian cancer. In the second aim we will define serum-derived sncRNAs correlates of ovarian cancer disease status. We will compare sera from ovarian cancer patients at times of highest and lowest disease burden to those of control, cancer-free subjects. Each aim will provide independent, novel, and important information for future investigations. The sncRNAs found to be differentially expressed in both aims will be prioritized for future validation in women under clinical surveillance for hereditary risk of ovarian cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women at average risk for ovarian cancer | – | –Women at average risk for ovarian cancer (no first degree relatives with breast or ovarian cancer) undergoing gynecologic evaluation at UVA for non-malignant or routine indications. |
| Women with ovarian cancer | – | –Women with known or suspected ovarian cancer who are undergoing evaluation and/or treatment at UVA Cancer Center |
| Increased risk for ovarian cancer | – | –Women at increased risk of ovarian cancer based on family history, personal history, or genetic factors defined as either BRCA1 or BRCA2 mutations who still retain both fallopian tubes and both ovaries. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women in Gynecologic clinics
Key inclusion criteria (6 listed)
- Undergoing medical care at UVA
- Up to date breast cancer screening
- Subjects must fall into one of the following groups:
Key exclusion criteria (2 listed)
- Subjects with increased risk for ovarian cancer may not have a history of prior malignancy within the last 10 years excluding cervical carcinoma in situ or basal cell carcinoma
- Pregnancy (self reported)
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
Defining sncRNA alterations associated with hereditary predisposition to ovarian cancer
Time frame: 24 months
Serum samples will be collected from patients with known BRCA mutations. As a control, we will recruit age-matched women undergoing gynecologic evaluation for benign disease without any personal or family history of cancer. The normal and BRCA mutation groups will be pooled for deep sequencing. Pooled sample short RNAs will be cloned and subjected to deep sequencing and bioinformatic analysis. Validation of 5-10 differentially expressed sncRNAs is performed by quantitative RT-PCR and Northern blots on individual control and high risk samples.
Identification of serum derived sncRNA biomarkers that correlate with disease burden in ovarian cancer.
Time frame: 24 months
In this aim pre- and post-remission samples from twenty women with stage III-IV ovarian cancer will be compared to twenty samples from control cancer-free subjects. Methods used will be essentially identical to those described above however, given the opportunity to use each patient as her own control and thus minimized confounders we believe deep sequencing of samples individually will provide better quality data and more robust statistical comparison.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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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.
Susan Modesitt, MD principal investigator
University of Virginia
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 Virginia 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Modesitt, MD (434-924-5197, scm6h@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defining sncRNA alterations associated with hereditary predisposition to ovarian cancer (time frame: 24 months). The study lists 2 primary outcomes in all. 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 5 Dec 2014.