Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340808
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2006-06-19
Brief Title:
Molecular Staging of Endometrial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Integration of an Epidemiologic Questionnaire Into Gynecologic Oncology Group Trials First Project Protocol 210
Status:
COMPLETED
Status Verified Date:
2020-07
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 sponsored by NCI and the Gynecologic Oncology Group GOG will collect tissue samples from women with cancer of the endometrium lining of the uterus Researchers will use the samples to learn more about endometrial cancer and develop new treatments and methods of prevention
Women with endometrial cancer who are suitable candidates for surgery and who have not had prior retroperitoneal surgery or pelvic or abdominal radiation therapy may be eligible for this study Candidates will be screened with a medical history and physical examination blood tests and endometrial biopsy surgical removal of a small tissue sample or dilation and curettage D C
Participants will undergo hysterectomy surgery to remove the uterus along with removal of both fallopian tubes and ovaries This is the standard surgical treatment for endometrial cancer Lymph nodes in the pelvis near the main blood vessel in the abdomen are also removed to determine if the disease has spread to these nodes If cancer is found involving other sites the cancer in those areas may also be removed examination of the tissues will determine if further therapy beyond surgery is needed
Before surgery patients will complete a 20-minute questionnaire that includes questions about their background reproductive history menstruation and menopause certain surgeries birth control pills and hormone replacement therapy other drugs and medicines weight and height smoking medical history and family history of cancer
Some of the tissue removed during surgery plus a urine sample collected from a catheter bag during surgery and blood drawn before surgery and at follow-up visits 6 weeks and 3 years after surgery will be sent to the GOG Tissue Bank in Columbus Ohio This bank stores processes and distributes biological specimens from patients that agree to participate in studies conducted by the GOG
Patients will have follow-up visits 6 weeks after surgery then every 6 months for the next 2 years followed annually for the next 7 years for a total 10-year follow-up The visits will include an examination and questions about health status and treatments received between visits Patients whose cancer returns or worsens will undergo another tumor biopsy if possible at that time
Women with endometrial cancer who are suitable candidates for surgery and who have not had prior retroperitoneal surgery or pelvic or abdominal radiation therapy may be eligible for this study Candidates will be screened with a medical history and physical examination blood tests and endometrial biopsy surgical removal of a small tissue sample or dilation and curettage D C
Participants will undergo hysterectomy surgery to remove the uterus along with removal of both fallopian tubes and ovaries This is the standard surgical treatment for endometrial cancer Lymph nodes in the pelvis near the main blood vessel in the abdomen are also removed to determine if the disease has spread to these nodes If cancer is found involving other sites the cancer in those areas may also be removed examination of the tissues will determine if further therapy beyond surgery is needed
Before surgery patients will complete a 20-minute questionnaire that includes questions about their background reproductive history menstruation and menopause certain surgeries birth control pills and hormone replacement therapy other drugs and medicines weight and height smoking medical history and family history of cancer
Some of the tissue removed during surgery plus a urine sample collected from a catheter bag during surgery and blood drawn before surgery and at follow-up visits 6 weeks and 3 years after surgery will be sent to the GOG Tissue Bank in Columbus Ohio This bank stores processes and distributes biological specimens from patients that agree to participate in studies conducted by the GOG
Patients will have follow-up visits 6 weeks after surgery then every 6 months for the next 2 years followed annually for the next 7 years for a total 10-year follow-up The visits will include an examination and questions about health status and treatments received between visits Patients whose cancer returns or worsens will undergo another tumor biopsy if possible at that time
Detailed Description:
GOG-210 is a molecular and surgico-pathological staging study of endometrial carcinoma The overall goal of this pilot protocol is to improve outcome andor quality of life for patients with endometrial cancer This fundamental goal will be accomplished through the development of more accurate models of risk identification of candidate targets for therapeutic intervention and utilization of individualized treatments based on molecular characteristics identified in tumor tissue normal tissue andor in readily accessible biological fluids like serum and urine This molecular and surgico-pathological staging study is structured to collect tissue urine serum and epidemiologic and clinical data from approximately 3500 patients with endometrial cancer identified at participating GOG institutions All of the patients will be surgically-pathologically staged consistently evaluated further treated as needed and followed for up to 10 years after surgery to document further treatment and outcome A series of independent and integrated research projects will be undertaken to utilize high-throughput methodologies eg genomics and proteomics and more traditional techniques eg immunoassays to examine cellular and extracellular factors including chromosomes DNA RNA proteins lipids and carbohydrates The results obtained from the comprehensive laboratory testing performed on these clinical specimens with the clinical and epidemiologic data collected for each GOG-0210 patient will represent an enduring resource for endometrial cancer research to study the factors that control the growth and spread of endometrial cancer and how to predict response to therapy and risk of disease spread recurrence and overall survival for patients with this disease This will be the first implementation of the NCI-developed epidemiologic questionnaire which will allow GOG protocols to systematically and uniformly collect demographic and epidemiologic data that will enhance the analytic capabilities of this study If successful this study will serve as a model for other protocol to implement the same epidemiologic questionnaire
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-N144 | None | None | None |