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Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer Clinical research trials and Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer. Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer clinical trial. Human subjects often get the best healthcare possible for their Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer
Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer
For Condition: stage 1 breast cancer,stage 2 breast cancer,perioperative/postoperative complications
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI),National Surgical Adjuvant Breast and Bowel Project (NSABP)
Synopsis: RATIONALE: Timing of breast cancer surgery may improve effectiveness of treatment and may help patients live longer. PURPOSE: Clinical trial to determine whether timing of primary surgery in relation to menstrual cycle is associated with disease-free survival 5 years after surgery in women who have stage I or stage II breast cancer.
Details: OBJECTIVES: - Document menstrual phase (follicular vs luteal) by circulating hormones and menstrual history at the time of primary surgery in premenopausal women with stage I or II breast cancer. - Correlate menstrual phase at primary surgery with 5-year disease-free survival in these patients. - Compare the menstrual cycle data obtained by hormone levels and study-specific menstrual cycle history with information recorded in the general written record. - Compare the menstrual cycle data (e.g., hormone levels and cycle history) for these women with the data for the general population. - Estimate the disease-free survival of women who undergo a 2-stage surgical procedure with cancer found at both stages when the surgery is not confined to the same menstrual cycle phase. OUTLINE: This is a multicenter study. Hormone levels and menstrual history are obtained within one calendar day to surgery. Patients undergo either one- or two-stage surgery (open biopsy followed immediately or later by mastectomy or breast-conserving surgery). Patients complete a questionnaire 6 months after surgery to assess the extent of adjuvant therapy received (if any) and a questionnaire 12 months after surgery to assess recurrence of breast cancer and vital status. Patients are followed annually for 10 years. PROJECTED ACCRUAL: A total of 1,100 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage I or II breast cancer - No prior breast cancer - Must have regular menstrual cycles (21-35 days) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 to 55 Sex: - Female Menopausal status: - Premenopausal Performance status: - Not specified Life expectancy: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant - No nursing within the past 3 months - No galactorrhea - No prior malignancy within the past 10 years except squamous cell or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Concurrent chemotherapy allowed Endocrine therapy: - At least 3 months since prior oral contraceptives Radiotherapy: - Concurrent radiotherapy allowed Surgery: - Complete surgical resection required prior to entry - One- or two-stage procedure (e.g., open biopsy followed immediately or later by mastectomy or breast-conserving approach) - Two-step registration required for patients undergoing two-stage procedure - Fine-needle aspiration (FNA), stereotactic, or core-needle biopsy is allowed at any time prior to open biopsy - Sentinel node dissection/axillary node dissection allowed Other: - No prior neoadjuvant therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CliveGrant, Study Chair, Mayo Clinic Cancer Center
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26102
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, 32207-8554
United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237
United States
Rockford Clinic
Rockford, Illinois, 61103
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
South Pointe Hospital
Cleveland, Ohio, 44122
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
St. Luke's Hospital and Health Network - Bethlehem
Bethlehem, Pennsylvania, 18015
United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, 44710-1799
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Canada
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
Puget Sound Oncology Consortium
Seattle, Washington, 98109
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45219-0502
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114-4199
United States
Warren Grant Magnuson Clinical Center
Bethesda, Maryland, 20892-1182
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Wellspan Health - York Cancer Center
York, Pennsylvania, 17403
United States
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, 39534-2576
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, 01805
United States
Jewish General Hospital - Montreal
Montreal, Quebec, H3T 1E2
Canada
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Akron City Hospital
Akron, Ohio, 44309-2090
United States
Community Regional Cancer Care
Indianapolis, Indiana, 46256
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
United States
Hartford Hospital
Hartford, Connecticut, 06102-5037
United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Scripps Cancer Center at Scripps Clinic
La Jolla, California, 92037
United States
Kent County Memorial Hospital
Warwick, Rhode Island, 02886
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15236
United States
Additional Information:
Study ID Numbers: CDR0000064717; NCCTG-N9431,NSABP-BI-65
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002762
Other Perioperative/postoperative Complications Studies:
1. Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
2. Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
3. Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma
4. Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
5. J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma
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Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer
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