Ovarian CancerNCT00478387
Ovarian Cancer and Immune Response to Flu Vaccine
An observational study of Ovarian Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to determine what the immune response is of ovarian cancer patients in remission, when they are given the flu vaccine. After receiving the flu vaccine, patients will have blood drawn 5 times in 12 months to study antibody response to the flu vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- The current season's trivalent killed influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: To gather preliminary information regarding immune response following influenza vaccination via measurement of antibody in subjects with advanced ovarian and primary peritoneal cancer in remission..
Who may be able to join
- All subjects must have a histologic diagnosis of epithelial ovarian cancer or primary peritoneal carcinoma. Time from completion of chemotherapy will be no more than 6 months.
- If no clinical evidence of disease is present after diagnosis with Stage III or IV disease and completion of primary surgery and chemotherapy, or, if no clinical evidence of disease is present after completion of chemotherapy for a disease recurrence diagnosed after a progression-free interval of at least 2 years, for patients of any initial stage.
Who cannot join
- Prior malignancy (except basal cell or squamous cell skin cancer) within the past five years.
- Presence of active CNS disease.
- Active bacterial, viral or fungal infections.
- Chemotherapy, biologic therapy, or radiation therapy < 4 weeks prior to study entry.
- History of active autoimmunity or immunosuppression.
- Use of immunosuppressive drugs within 4 weeks prior to study entry. Patients may receive chemotherapy or other immunosuppressive medications at the discretion of their physician during the subsequent year after influenza vaccination without exclusion from the study.
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- Patients with tumors of low malignant potential (borderline tumors) will not be eligible.
- Prior influenza vaccination with the current vaccine.
- History of serious sensitivity to eggs, or previous influenza vaccine.
- Pregnant of breastfeeding subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Obstetrics and Gynecology, Division of GYN Oncology, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Study of the Immunogenicity of Killed Influenza Vaccine in Patients With Ovarian, Fallopian Tube, and Primary Peritoneal Cancer in Remission
The purpose of this study is to determine what the immune response is of ovarian cancer patients in remission, when they are given the flu vaccine. After receiving the flu vaccine, patients will have blood drawn 5 times in 12 months to study antibody response to the flu vaccine.
- Conditions
- Ovarian Cancer
- Being tested
- The current season's trivalent killed influenza vaccine
- Keywords
- Advanced Ovarian and Primary Peritoneal Cancer in Remission
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The current season's trivalent killed influenza vaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startOct 2006
- Primary completionJun 2011
- Study completionJun 2011
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 PennsylvaniaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Christina S Chu, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478387
- Sponsor's protocol ID
- 805443
- Other IDs
- UPCC 5806 (N01-A1-50024)
- Status last verified
- Oct 2016
- First submitted
- 22 May 2007
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Immunogenicity of Killed Influenza Vaccine in Patients With Ovarian, Fallopian Tube, and Primary Peritoneal Cancer in Remission
- ClinicalTrials.gov ID
- NCT00478387
- Acronym / sponsor ID
- 805443
- Conditions
- Ovarian Cancer
- Keywords
- Advanced Ovarian and Primary Peritoneal Cancer in Remission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 May 2007 (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 determine what the immune response is of ovarian cancer patients in remission, when they are given the flu vaccine. After receiving the flu vaccine, patients will have blood drawn 5 times in 12 months to study antibody response to the flu vaccine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To gather preliminary information regarding immune response following influenza vaccination via measurement of antibody in subjects with advanced ovarian and primary peritoneal cancer in remission..
Key inclusion criteria (2 listed)
- All subjects must have a histologic diagnosis of epithelial ovarian cancer or primary peritoneal carcinoma. Time from completion of chemotherapy will be no more than 6 months.
- If no clinical evidence of disease is present after diagnosis with Stage III or IV disease and completion of primary surgery and chemotherapy, or, if no clinical evidence of disease is present after completion of chemotherapy for a disease recurrence diagnosed after a progression-free interval of at least 2 years, for patients of any initial stage.
Key exclusion criteria (10 listed)
- Prior malignancy (except basal cell or squamous cell skin cancer) within the past five years.
- Presence of active CNS disease.
- Active bacterial, viral or fungal infections.
- Chemotherapy, biologic therapy, or radiation therapy < 4 weeks prior to study entry.
- History of active autoimmunity or immunosuppression.
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 |
|---|---|---|
| The current season's trivalent killed influenza vaccine | Biological | – |
Primary outcome
Not reported in the source record.
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 5 Oct 2016.
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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.
Christina S Chu, MD principal investigator
University of Pennsylvania
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 Pennsylvania 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 2 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 5 Oct 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.
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.
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 Oct 2016.