Molecular Staging of Endometrial Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Cancer, Endometrial Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 1/31/2019 |
| Start Date: | March 19, 2004 |
Integration of an Epidemiologic Questionnaire Into Gynecologic Oncology Group Trials: First Project, Protocol 210
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.
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.
GOG-210 is a molecular and surgico-pathological staging study of endometrial carcinoma. The
overall goal of this pilot protocol is to improve outcome and/or 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 and/or 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 3,500
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 (e.g., genomics and proteomics) and more traditional
techniques (e.g., 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.
overall goal of this pilot protocol is to improve outcome and/or 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 and/or 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 3,500
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 (e.g., genomics and proteomics) and more traditional
techniques (e.g., 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.
- INCLUSION CRITERIA:
- Patients with endometrial carcinoma diagnosed by an endometrial biopsy or dilation and
curettage who will undergo full surgical staging; all stages, grades and histologic
subtypes will be eligible.
- Patients must be suitable candidates for surgery. Patients may also be entered on
GOG-2222 (LAP2).
- Patients who have signed an approved Informed Consent.
- Patients who have met the pre-entry requirements specified in the Study Parameters.
- Patients with a prior malignancy (at least 5 years since diagnosis) with no current
evidence of disease.
EXCLUSION CRITERIA:
- Patients not considered suitable candidates for surgery.
- Patients who have had prior retroperitoneal surgery.
- Patients who have received prior pelvic or abdominal radiation therapy.
- Patients who are pregnant.
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