Fallopian Tube CancerNCT00897039
Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
An observational study of Fallopian Tube Cancer and Ovarian Cancer, run by Southeastern Gynecologic Oncology at 1 site in United States.
Trial summary
RATIONALE: Collecting samples of tissue from patients with cancer to study in the laboratory may help doctors predict how well patients will respond to treatment with certain chemotherapy drugs and plan the best treatment. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- flow cytometry and immunohistochemistry staining method
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to not given
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Pathologically confirmed adenocarcinoma of 1 of the following types:
- Ovarian
- Primary peritoneal
- Fallopian tube
- Must meet 1 of the following criteria:
- De novo malignancy with no prior chemotherapy
- Advanced refractory malignancy with ≤ 2 standard chemotherapy treatment protocols
- Tumor must be accessible for biopsy or drainage of effusions
- Chemotherapy is considered a treatment option
- No symptomatic or uncontrolled parenchymal brain metastases
- No meningeal metastasis
PATIENT CHARACTERISTICS:
- Not pregnant
- Negative pregnancy test
- Fertile patients must agree to use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southeastern Gynecologic Oncology, LLP - Northside
Atlanta, Georgia, 30342
Clinical Trials Office - Southeastern Gynecologic Oncology, LL, 678-420-4154
About this study
Official title: Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas
RATIONALE: Collecting samples of tissue from patients with cancer to study in the laboratory may help doctors predict how well patients will respond to treatment with certain chemotherapy drugs and plan the best treatment.
PURPOSE: This laboratory study is looking at tumor tissue samples to predict response to chemotherapy in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Read the detailed description
OBJECTIVES:
- Evaluate the ability of the microculture kinetic (MiCK) assay to predict the outcome of patients with ovarian, fallopian tube, or primary peritoneal adenocarcinoma treated with first-line chemotherapy.
- Evaluate the ability of the MiCK assay to guide chemotherapy in a third-line, refractory treatment setting (exclusive of anti-vascular endothelial growth factor) in these patients.
OUTLINE: Patients are stratified according to prior chemotherapy (no [stratum I] vs yes [stratum II]).
Tumor tissue and/or effusion specimens are collected at baseline. Specimens are examined by the microculture kinetic (MiCK) assay and immunocytochemical or flow cytometry assay.
MiCK assay results do not influence treatment for stratum I patients. Stratum II patients may receive treatment based on MiCK assay results for tumor sensitivity to specific chemotherapy drugs.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
- Being tested
- flow cytometry, immunohistochemistry staining method
- Keywords
- ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma, recurrent ovarian epithelial cancer, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian mucinous cystadenocarcinoma, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, recurrent primary peritoneal cavity cancer, stage IA primary peritoneal cavity cancer, stage IB primary peritoneal cavity cancer, stage IC primary peritoneal cavity cancer, stage IIA primary peritoneal cavity cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of a statistically significant discriminator of sensitivity with complete response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube 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
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeastern Gynecologic Oncology
- Sponsor type
- University, hospital or other
- Investigators
- Vladimir D. Kravtsov, MD, Study chair, Pierian BiosciencesMatthew O. Burrell, MD, Southeastern Gynecologic Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897039
- Sponsor's protocol ID
- CDR0000491440
- Other IDs
- SEG-20060042, SEG-IRB-1075624
- Status last verified
- Jul 2009
- First submitted
- 9 May 2009
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas
- ClinicalTrials.gov ID
- NCT00897039
- Acronym / sponsor ID
- CDR0000491440
- Keywords
- ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma, recurrent ovarian epithelial cancer, ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian mucinous cystadenocarcinoma, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southeastern Gynecologic OncologyUniversity, hospital or other
- Study start
- Mar 2006
- First posted
- 12 May 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.
RATIONALE: Collecting samples of tissue from patients with cancer to study in the laboratory may help doctors predict how well patients will respond to treatment with certain chemotherapy drugs and plan the best treatment.
PURPOSE: This laboratory study is looking at tumor tissue samples to predict response to chemotherapy in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Detailed description
OBJECTIVES:
- Evaluate the ability of the microculture kinetic (MiCK) assay to predict the outcome of patients with ovarian, fallopian tube, or primary peritoneal adenocarcinoma treated with first-line chemotherapy.
- Evaluate the ability of the MiCK assay to guide chemotherapy in a third-line, refractory treatment setting (exclusive of anti-vascular endothelial growth factor) in these patients.
OUTLINE: Patients are stratified according to prior chemotherapy (no [stratum I] vs yes [stratum II]).
Tumor tissue and/or effusion specimens are collected at baseline. Specimens are examined by the microculture kinetic (MiCK) assay and immunocytochemical or flow cytometry assay.
MiCK assay results do not influence treatment for stratum I patients. Stratum II patients may receive treatment based on MiCK assay results for tumor sensitivity to specific chemotherapy drugs.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| flow cytometry | Other | – |
| immunohistochemistry staining method | Other | – |
Primary outcome
Correlation of a statistically significant discriminator of sensitivity with complete response rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
Vladimir D. Kravtsov, MD study chair
Pierian Biosciences
Matthew O. Burrell, MD
Southeastern Gynecologic Oncology
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 Fallopian Tube Cancer and Ovarian Cancer, run by Southeastern Gynecologic Oncology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of a statistically significant discriminator of sensitivity with complete response rate. 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 Sep 2013.