Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Uterine Cervical Neoplasms

Recurrence

Carcinoma

Breast Neoplasms

Prostatic Neoplasms

Sarcoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Vaginal Neoplasms

Vulvar Neoplasms

Breast Neoplasms, Male

Endometrial Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Breast Diseases

Skin Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Vulvar Diseases

Vaginal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Vaginal Cancer

Breast Cancer, Male

Germ Cells Tumors

Fallopian Tube Cancer

Vulvar Cancer

Ovarian Germ Cell Tumor

Uterine Sarcoma

gene expression analysis

gene rearrangement analysis

polymorphism analysis

laboratory biomarker analysis

radiation therapy

Contact Person

Catherine West

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is evaluating DNA mutations in predicting the effect of external-beam radiation therapy in patients with early breast cancer, localized prostate cancer, or gynecologic cancer.

OBJECTIVES:

Primary

* To test the hypothesis that an association between common genetic variations, reported by single nucleotide polymorphisms (SNP) in relevant candidate genes, is associated with individual patient variability in normal tissue radiation response and toxicity.

Secondary

* To compare different clinical scoring systems for late normal tissue effects, specifically Late Effect of Normal Tissue Subjective Objective Management Analysis (LENT SOMA), Radiation Therapy Oncology Group (RTOG), quality of life, and in a subset common terminology criteria (CTC) version 3.
* To compare clinical scoring systems with analytical measures of normal tissue outcome in a minority of patients, using volume change in the breast measured by laser camera.
* To correlate family history information with SNP analysis to produce a polymorphism risk score (PRS) for family history.
* To compare a detailed 3D dose-volume analysis in a subset of patients with late effects and SNP results.
* To correlate actuarial analysis of late effects changes over time with PRS.
* To conduct PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability.

OUTLINE: This is a multicenter study.

Patients are recruited from clinical trials in which their late normal tissue effects have been measured. Blood samples are collected from these patients for analysis of genetic variation by DNA extraction and single nucleotide polymorphism analysis. Sixty different genes, including those involved in cell cycle checkpoint control, DNA damage recognition and repair, induction of apoptosis, and cytokine production (including TGFβ pathways) are assessed.

Study of DNA Mutations in Predicting the Effect of External-Beam Radiation Therapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer

Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)

The Christie NHS Foundation Trust

Blood and Lymph Conditions

Lymphedema

Lymphatic Diseases

Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014)

Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open route.

Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy +/- para-aortic node sampling.

Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24 months.

Quality-of-Life Assessment

Questionnaire Administration

Study of High Risk Factors

Therapeutic Conventional Surgery

Therapeutic Laparoscopic Surgery

Therapeutic Lymphadenectomy

Richard Barakat

This clinical trial studies lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer. Collecting information over time about how often lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer, cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the best treatment.

PRIMARY OBJECTIVES:

I. To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy with a concurrent lymphadenectomy for a gynecologic malignancy.

II. To identify risk factors for the development of lower extremity lymphedema following radical surgery among patients with any one of the three types of gynecologic malignancy studied and to develop a corresponding predictive model.

SECONDARY OBJECTIVES:

I. To identify the effect that lower extremity lymphedema has on quality of life (QOL) (as measured with Functional Assessment of Cancer Therapy - General \[FACT-G\] + disease specific subscale), psychological adjustment (as measured with Impact of Events Scale \[IES\] and Functional Assessment of Chronic Illness Therapy \[FACIT\] body image items) and physical disability (of lower extremity as measured with Lower Extremity Functional Scale \[LEFS\]) and physical function(as measured by FACT-Functional Wellbeing \[FW\] subscale, FACIT disease specific items \& patient-reported outcomes measurement information system \[PROMIS\] items) and to investigate potential protective mechanisms (FACT-Social Wellbeing \[SW\] subscale and patient characteristics).

II. To explore if patient self-reported symptoms (as measured with the lymphedema \[LE\] Symptom Measure \[Cancer Lymphedema Questionnaire (GCLQ)\]) are associated with the development of lymphedema in patients undergoing radical surgery for gynecologic malignancy.

TERTIARY OBJECTIVES:

I. To explore the effect of moderate or severe lymphedema (primary endpoint) on QOL outcomes, as measured by the FACT-General (G) questionnaire.

OUTLINE:

Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014)

Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open route.

Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy +/- para-aortic node sampling.

Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24 months.

Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer

The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients

A competing risks analysis will be required to estimate the cumulative incidence of lymphedema. Transition probabilities in the Markov Chain will be estimated by simple proportions, ignoring covariates, to address this primary objective. Confidence intervals for the cumulative incidence of lymphedema then will be computed using the Delta Method, utilizing the fact that the transition proportions have and asymptotic multivariate normal distribution.

If risk factors are identified, a model will be developed to predict the level of risk (low, moderate, high) of lymphedema following gynecologic cancer treatment overall, and following treatment for endometrial cancer specifically. The predictive power of the models for these rates will be assessed.

Whether the patient self-reported symptoms are associated with the development of lymphedema wit be explored.

As measured by the FACT QOL scale, psychological adjustment as measured by the Impact of Events Subscale (IES), and FACIT body image items, physical disability as measured by the Lower Extremity Functional Scale -(LEFS) and PROs of physical health status/function (sexual), as measured by FACT-FW; FACIT \& PROMIS.

National Cancer Institute (NCI)

Gynecologic Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of DNA Mutations in Predicting the Effect of External-Beam Radiation Therapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer	NCT00601406	Breast Cancer Cervical Cancer Endometrial Can... Fallopian Tube ... Ovarian Cancer Primary Periton... Prostate Cancer Sarcoma Vaginal Cancer Vulvar Cancer	gene expression... gene rearrangem... polymorphism an... laboratory biom... radiation thera...	-	National Cancer Institute (NCI)
Study of DNA Mutations in Predicting the Effect of External-Beam Radiation Therapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer	NCT00601406	Breast Cancer Cervical Cancer Endometrial Can... Fallopian Tube ... Ovarian Cancer Primary Periton... Prostate Cancer Sarcoma Vaginal Cancer Vulvar Cancer	gene expression... gene rearrangem... polymorphism an... laboratory biom... radiation thera...	-	National Cancer Institute (NCI)
Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer	NCT00956670	Lymphedema Stage IA Cervic... Stage IA Uterin... Stage IA Vulvar... Stage IB Cervic... Stage IB Uterin... Stage IB Vulvar... Stage II Uterin... Stage II Vulvar... Stage IIA Cervi... Stage IIIA Vulv... Stage IIIB Vulv... Stage IIIC Vulv... Stage IVB Vulva...	Quality-of-Life... Questionnaire A... Study of High R... Therapeutic Con... Therapeutic Lap... Therapeutic Lym...	18 Years -	GOG Foundation
Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer	NCT00956670	Lymphedema Stage IA Cervic... Stage IA Uterin... Stage IA Vulvar... Stage IB Cervic... Stage IB Uterin... Stage IB Vulvar... Stage II Uterin... Stage II Vulvar... Stage IIA Cervi... Stage IIIA Vulv... Stage IIIB Vulv... Stage IIIC Vulv... Stage IVB Vulva...	Quality-of-Life... Questionnaire A... Study of High R... Therapeutic Con... Therapeutic Lap... Therapeutic Lym...	18 Years -	GOG Foundation

Spots Global Cancer Trial Database for stage ib vulvar cancer