Ovarian Serous CystadenocarcinomaNCT00053235
Research Study in Patients With Advanced Ovarian Epithelial Cancer
An observational study of Ovarian Serous Cystadenocarcinoma and Ovarian Serous Surface Papillary Adenocarcinoma, run by Gynecologic Oncology Group at 1 site in United States.
Trial summary
This research trial studies tissue samples from patients with ovarian cancer in the laboratory. Analyzing tissue samples from patients in the laboratory may help doctors learn more about cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Serous Cystadenocarcinoma, Ovarian Serous Surface Papillary Adenocarcinoma, Stage IIIA Ovarian Cancer
- What is being tested?
- Comparative Genomic Hybridization, Laboratory Biomarker Analysis and Polymerase Chain Reaction
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Aug 2010
- 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
Who may be able to join
- Stage III or IV, high-grade (grade 2 or 3) ovarian cancers
- No borderline or low-grade (grade 1) tumors
- Tissue from predominately serous ovarian cancer only
- No clear cell, endometrioid, mucinous, transitional cell, or mixed without predominant serous component
- Tissue obtained during prior optimal or suboptimal cytoreductive surgery
- Must be enrolled on GOG-0136 and a GOG front-line paclitaxel/platinum chemotherapy trial
- Frozen tissue and hematoxylin-eosin stained section from the ovary obtained at initial surgery
- Performance status - GOG 0-2
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: A Pilot Study to Correlate DNA Sequence Copy Number Abnormalities With Outcome in Patients With Advanced Epithelial Ovarian Cancer
This research trial studies tissue samples from patients with ovarian cancer in the laboratory. Analyzing tissue samples from patients in the laboratory may help doctors learn more about cancer.
Read the detailed description
OBJECTIVES:
- Utilize array comparative genomic hybridization and Taqman analyses, a quantitative genomic polymerase chain reaction, to validate the observation that a gain in chromosome 8q is predictive of shorter progression-free survival in patients with primary grade 2 or grade 3 advanced serous papillary ovarian cancer.
II. Utilize these analyses to determine whether a gain in chromosome 8q is predictive of worse overall survival in these patients.
III. Utilize these analyses to determine whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome in these patients and the association between these changes and clinical characteristics.
IV. Utilize these analyses to identify up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) in these patients.
OUTLINE:
Genomic DNA is isolated from optimal cutting temperature (OCT)-embedded tissue and analyzed using comparative genomic hybridization. The chromosomal changes identified by this method are compared to those identified using the Taqman method, a quantitative genomic polymerase chain reaction analysis. Chromosome 8q is of specific interest. Other chromosomal changes may be detected in chromosomes 3q, 7q, 16q, and/or 17pter-q21.
- Conditions
- Ovarian Serous Cystadenocarcinoma, Ovarian Serous Surface Papillary Adenocarcinoma, Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer, Stage IV Ovarian Cancer
- Being tested
- Comparative Genomic Hybridization, Laboratory Biomarker Analysis, Polymerase Chain Reaction
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparative Genomic HybridizationGenetic
Also called CGH, Comparative Genome Hybridization, Comparative Genomic Analysis
Correlative studies
Laboratory Biomarker AnalysisOther
Correlative studies
Polymerase Chain ReactionGenetic
Also called PCR
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative | Genomic DNA is isolated from OCT-embedded tissue and analyzed using comparative genomic hybridization. The chromosomal changes identified by this method are compared to those identified using the Taqman method, a quantitative genomic polymerase chain reaction analysis. Chromosome 8q is of specific interest. Other chromosomal changes may be detected in chromosomes 3q, 7q, 16q, and/or 17pter-q21. Receives: Genetic: Comparative Genomic Hybridization; Other: Laboratory Biomarker Analysis; Genetic: Polymerase Chain Reaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between above chromosomal changes and clinical characteristics
Measured: baseline
Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients
Measured: baseline
Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome
Measured: baseline
Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival)
Measured: baseline
Validation of the observation that a gain in chromosome 8q is predictive of shorter progression-free survival in patients with primary grade 2 or grade 3 advanced serous papillary ovarian cancer by PCR and Taqman analyses
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startNov 2002
- Primary completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Serous CystadenocarcinomaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Gershenson, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053235
- Sponsor's protocol ID
- GOG-8004
- Other IDs
- NCI-2009-00612, CDR0000269315, GOG-8004, GOG-8004
- Status last verified
- May 2015
- First submitted
- 27 Jan 2003
- Last updated
- 1 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Correlate DNA Sequence Copy Number Abnormalities With Outcome in Patients With Advanced Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00053235
- Acronym / sponsor ID
- GOG-8004
- Conditions
- Ovarian Serous Cystadenocarcinoma, Ovarian Serous Surface Papillary Adenocarcinoma, Stage IIIA Ovarian Cancer, Stage IIIB Ovarian Cancer, Stage IIIC Ovarian Cancer, Stage IV Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2002
- Primary completion
- Aug 2010 (actual)
- First posted
- 28 Jan 2003 (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.
This research trial studies tissue samples from patients with ovarian cancer in the laboratory. Analyzing tissue samples from patients in the laboratory may help doctors learn more about cancer.
Detailed description
OBJECTIVES:
- Utilize array comparative genomic hybridization and Taqman analyses, a quantitative genomic polymerase chain reaction, to validate the observation that a gain in chromosome 8q is predictive of shorter progression-free survival in patients with primary grade 2 or grade 3 advanced serous papillary ovarian cancer.
II. Utilize these analyses to determine whether a gain in chromosome 8q is predictive of worse overall survival in these patients.
III. Utilize these analyses to determine whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome in these patients and the association between these changes and clinical characteristics.
IV. Utilize these analyses to identify up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) in these patients.
OUTLINE:
Genomic DNA is isolated from optimal cutting temperature (OCT)-embedded tissue and analyzed using comparative genomic hybridization. The chromosomal changes identified by this method are compared to those identified using the Taqman method, a quantitative genomic polymerase chain reaction analysis. Chromosome 8q is of specific interest. Other chromosomal changes may be detected in chromosomes 3q, 7q, 16q, and/or 17pter-q21.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative | – | Genetic: Comparative Genomic Hybridization, Other: Laboratory Biomarker Analysis, Genetic: Polymerase Chain ReactionGenomic DNA is isolated from OCT-embedded tissue and analyzed using comparative genomic hybridization. The chromosomal changes identified by this method are compared to those identified using the Taqman method, a quantitative genomic polymerase chain reaction analysis. Chromosome 8q is of specific interest. Other chromosomal changes may be detected in chromosomes 3q, 7q, 16q, and/or 17pter-q21. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Stage III or IV, high-grade (grade 2 or 3) ovarian cancers
- Tissue obtained during prior optimal or suboptimal cytoreductive surgery
- Must be enrolled on GOG-0136 and a GOG front-line paclitaxel/platinum chemotherapy trial
- Frozen tissue and hematoxylin-eosin stained section from the ovary obtained at initial surgery
- Performance status - GOG 0-2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Comparative Genomic HybridizationAlso: CGH, Comparative Genome Hybridization, Comparative Genomic AnalysisCorrelative studies | Genetic | Ancillary-Correlative |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative |
| Polymerase Chain ReactionAlso: PCRCorrelative studies | Genetic | Ancillary-Correlative |
Primary outcome
Association between above chromosomal changes and clinical characteristics
Time frame: baseline
Determination of whether a gain in chromosome 8q is predictive of worse overall survival in these patients
Time frame: baseline
Determination of whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome
Time frame: baseline
Identification of up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival)
Time frame: baseline
Validation of the observation that a gain in chromosome 8q is predictive of shorter progression-free survival in patients with primary grade 2 or grade 3 advanced serous papillary ovarian cancer by PCR and Taqman analyses
Time frame: baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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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.
David Gershenson principal investigator
Gynecologic Oncology Group
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 Serous Cystadenocarcinoma and Ovarian Serous Surface Papillary Adenocarcinoma, run by Gynecologic Oncology Group 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 8 inclusion and 0 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: withdrawn, as of the sponsor's last update on 1 Jun 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Association between above chromosomal changes and clinical characteristics (time frame: baseline). The study lists 5 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 1 Jun 2015.