Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086567
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2004-07-02
Brief Title:
Predictors of Relapse of Ovarian Peritoneal and Fallopian Tube Cancers
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Multi-Institutional Study of Proteomic Evaluation of Epithelial Ovarian Cancer Primary Peritoneal Cancer and Fallopian Tube Cancer Patients in First Clinical Remission Development of a Protein Fingerprint Profile of Relapse
Status:
COMPLETED
Status Verified Date:
2024-09-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will develop a blood test that can be used to predict a relapse of ovarian peritoneal or fallopian tube cancer The type of testing is called proteomics or the study of proteins in living cells The test will identify certain proteins that might represent a pattern or fingerprint indicating increased risk of disease relapse
Women with Stage III or IV epithelial ovarian cancer primary peritoneal cancer or fallopian tube cancer that is in remission may be eligible for this study Candidates are screened with a medical history and physical examination blood tests review of pathology report from surgery and computed tomography CT or magnetic resonance imaging MRI scans of the abdomen and pelvis and chest if the cancer spread to the chest
Participants have a clinic visit every 3 months for a physical examination including a pelvic examination blood draw for routine and research tests and review of how they have been feeling Every 6 months they have CT scans of the abdomen pelvis and possibly the chest When a patient has been in remission for 4 years blood draws are done every 6 months and CT scans are done yearly Patients whose cancer returns based on a CA-125 blood test CT scans or physical examination end their participation in the study Patients with an abnormal CT scan or physical examination may be asked to undergo a tumor biopsy surgical removal of a piece of tumor tissue for research purposes
Women with Stage III or IV epithelial ovarian cancer primary peritoneal cancer or fallopian tube cancer that is in remission may be eligible for this study Candidates are screened with a medical history and physical examination blood tests review of pathology report from surgery and computed tomography CT or magnetic resonance imaging MRI scans of the abdomen and pelvis and chest if the cancer spread to the chest
Participants have a clinic visit every 3 months for a physical examination including a pelvic examination blood draw for routine and research tests and review of how they have been feeling Every 6 months they have CT scans of the abdomen pelvis and possibly the chest When a patient has been in remission for 4 years blood draws are done every 6 months and CT scans are done yearly Patients whose cancer returns based on a CA-125 blood test CT scans or physical examination end their participation in the study Patients with an abnormal CT scan or physical examination may be asked to undergo a tumor biopsy surgical removal of a piece of tumor tissue for research purposes
Detailed Description:
Background
Over 80 of patients with advanced stage epithelial ovarian cancer will relapse
Serum biomarkers are needed for predictors of persistent disease and relapse
CA-125 is a less than satisfactory clinical tool for detecting relapse
A serum repository of samples from women with ovarian cancer is needed to develop and validate the multiple tests being created for ovarian cancer recurrence and screening
Objectives
To create a multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated
To determine the sensitivity and specificity of the proteomic signature profiles for relapse
To compare the accuracy of proteomic evaluation and CA125 in classifying patient disease progression
To identify the temporal relationship between a rise in CA125 value versus the development of proteomic signature profiles of relapse
To detect the impact of study participation on quality of life
To collect epidemiological data for patients in the target population
Eligibility
Patients in first remission from treatment of FIGO stage IIIIV primary peritoneal fallopian tube or epithelial ovarian carcinoma as defined by normal CA125 no evidence of disease on abdominopelvic CT scan and normal post-hysterectomy physical exam
Entry within 12 weeks of last administration of chemotherapy
SP surgical debulking and completion of primary therapy with platinumtaxane-containing chemotherapy of no more than a total of 8 cycles
Laboratory evidence of good end organ function
Design
Phase of Trial BiomarkerLaboratory Analysis
Number of patients to be enrolled 400
Planned statistical analysis for primary endpoint Training set to include 100 women half of whom are in remission and half of whom have recurrent disease Validation set will include 200 women half of whom are in remission and half of whom have recurrent disease
Over 80 of patients with advanced stage epithelial ovarian cancer will relapse
Serum biomarkers are needed for predictors of persistent disease and relapse
CA-125 is a less than satisfactory clinical tool for detecting relapse
A serum repository of samples from women with ovarian cancer is needed to develop and validate the multiple tests being created for ovarian cancer recurrence and screening
Objectives
To create a multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated
To determine the sensitivity and specificity of the proteomic signature profiles for relapse
To compare the accuracy of proteomic evaluation and CA125 in classifying patient disease progression
To identify the temporal relationship between a rise in CA125 value versus the development of proteomic signature profiles of relapse
To detect the impact of study participation on quality of life
To collect epidemiological data for patients in the target population
Eligibility
Patients in first remission from treatment of FIGO stage IIIIV primary peritoneal fallopian tube or epithelial ovarian carcinoma as defined by normal CA125 no evidence of disease on abdominopelvic CT scan and normal post-hysterectomy physical exam
Entry within 12 weeks of last administration of chemotherapy
SP surgical debulking and completion of primary therapy with platinumtaxane-containing chemotherapy of no more than a total of 8 cycles
Laboratory evidence of good end organ function
Design
Phase of Trial BiomarkerLaboratory Analysis
Number of patients to be enrolled 400
Planned statistical analysis for primary endpoint Training set to include 100 women half of whom are in remission and half of whom have recurrent disease Validation set will include 200 women half of whom are in remission and half of whom have recurrent disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-C-0232 | None | None | None |