NCT00897442已完成不适用
Acquisition of Human Gynecologic Specimens to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 187
- 主要终点
- Create a repository for long-term storage of these specimens
研究概览
简要总结
This laboratory study is collecting tumor tissue and blood samples from patients with gynecologic tumors. Collecting and storing samples of tumor tissue and blood from patients with cancer to study in the laboratory may help in the study of cancer.
详细描述
PRIMARY OBJECTIVES:
I. To collect gynecologic tissue and blood from participating Gynecologic Oncology Group (GOG) institutions.
II. To provide a repository for long-term storage of gynecologic tissue and blood that will be used in studies designed to better understand the molecular biology of gynecologic tumors.
III. To make available, through the GOG Tissue Bank, tissue and blood for proposed projects conducted by GOG and non-GOG investigators.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any of the following:
- •Patients who have had gynecologic tissue removed during surgery to diagnosis, treat, monitor, and/or prevent primary, persistent, or recurrent gynecologic cancer of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, or vulva, meeting at least one of the following criteria:
- •Group A: Women who underwent surgery, were diagnosed with a primary gynecologic malignancy of the ovary, cervix, uterine corpus, or vulva, and have primary tumor, normal tissue, and blood available for submission for this protocol
- •Patients with ovarian cancer including all stages, grades, and common epithelial cell types
- •Invasive cancers and serous and mucinous borderline tumors of low malignant potential are allowed
- •At least 1 gram of frozen primary tumor tissue must be submitted for this protocol for patients with FIGO stage III or IV epithelial ovarian cancer
- •Patients with an invasive malignancy of the cervix or uterine corpus including all stages, grades, and common cell types
- •Patients with squamous cell carcinoma of the vulva
- •Group B: Women who underwent surgery and were diagnosed with a rare gynecologic malignancy of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, vulva, a gestational trophoblastic tumor, or a tumor arising in endometriosis, and have tumor tissue available for submission for this protocol
- •Patients with a rare gynecologic malignancy of the ovary including malignant germ cell tumors; sex cord-stromal tumors; malignant mixed mesodermal tumors; clear cell, mucinous, small cell, or transitional cell carcinomas; malignant Brenner tumors; or borderline tumors of low malignant potential (except serous and mucinous)
- •Patients with a rare gynecologic malignancy of the peritoneum, including primary peritoneal cancer or mesothelioma
- •Patients with carcinoma of the fallopian tube
- •Patients with a rare gynecologic malignancy of the cervix including verrucous, small cell, clear cell, serous, or adenoid cystic carcinomas; carcinoid tumors; malignant mixed mesodermal tumors; or leiomyosarcoma
- •Patients with a rare gynecologic malignancy of the uterine corpus including leiomyosarcoma; malignant mixed mesodermal tumors; endometrial stromal sarcomas; smooth muscle tumors of unknown malignant potential; or clear cell or small cell carcinomas
- •Patients with a rare gynecologic malignancy of the vagina including verrucous or clear cell carcinomas; melanoma; embryonal rhabdomyosarcoma; or endodermal sinus tumor
- •Patients with a rare gynecologic malignancy of the vulva including verrucous carcinoma; melanoma; aggressive angiomyxoma; sarcoma; malignant Paget's disease; or Bartholin gland carcinoma
- •Patients with a gestational trophoblastic tumor
- •Patients with a tumor arising in endometriosis
- •Group C: Women who underwent prophylactic oophorectomy and have at least 1 gram of ovarian tissue and blood available for submission for this protocol
- •Group D: Women who underwent surgery to monitor or treat a persistent or recurrent gynecologic malignancy of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, or vulva, and have persistent or recurrent tumor, normal tissue, and blood available for submission for this protocol
- •Concurrent primary cancers are allowed
- •No benign cystic tumors of the ovary, including cystic epithelial tumors and mature cystic teratomas
- •Prior cytotoxic chemotherapy allowed
- •Prior hormonal therapy allowed
- •Prior radiotherapy allowed
- •Prior surgery allowed
- •No more than 6 weeks after prior surgery
排除标准
- 未提供
结局指标
主要结局
Create a repository for long-term storage of these specimens
时间窗: Baseline
Make available tissue and blood for proposed projects
时间窗: Baseline
Collection of gynecological tumor specimens and serum from patients at GOG institutions
时间窗: Baseline
次要结局
未报告次要终点
研究者
研究点 (187)
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