araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy

Summary: RATIONALE: Studying samples of tumor tissue 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 the study of cancer in the future.
  PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.

Detailed description: OBJECTIVES:
  -  Develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy.
  -  Develop a survival model for relapse based on sentinel lymph node biopsy positivity.
  -  Assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma.
  OUTLINE: This is a retrospective, case-controlled, multicenter study. Patients are stratified according to Breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs > 4 mm) and gender.
  Archived tumor tissue is analyzed by immunohistochemistry (IHC) for AP2, vascular endothelial growth factor, MMP 2, MCM4, and others, if feasible. Sentinel node biopsies are analyzed by IHC for CD31, LYVE-1, and D2-40 expression. RNA and DNA are also extracted for genetic expression studies and mutation analysis (e.g., BRAF, NRAS, PTEN, CDKN2A).
  Patient data related to relapse and recurrence is collected, if available.
  Peer reviewed and funded or endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Confirmed diagnosis of cutaneous melanoma
  -  Breslow thickness > 0.75 mm
  -  Has undergone sentinel lymph node biopsy
  -  No primary melanoma that has not originated in the skin
  -  No multiple primary melanomas
  -  Currently under clinical followup OR discharged from follow up within the past 3 months
  PATIENT CHARACTERISTICS:
  -  No other malignancy except for nonmelanoma skin cancer or cervical carcinoma in situ
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Study of Tumor Samples From Patients With Ewing Sarcoma

Summary: This laboratory study is looking at tumor samples from patients with Ewing sarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Detailed description: Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Samples collected from AEWS0031 and patients registered on AEWS08B1 Sampling Method: Non-Probability Sample
  PRIMARY OBJECTIVES:
  I. Determine if mutation of p53, and/or deletion of the p16 locus, have prognostic value in patients with Ewing sarcoma.
  SECONDARY OBJECTIVES:
  I. Estimate the incidence of p53 mutation in Ewing sarcoma samples collected from COG studies.
  II. Estimate the incidence of p16 deletions in Ewing sarcoma samples collected from COG studies.
  III. Prepare and archive amplified genomic DNA from Ewing sarcoma samples collected from COG studies for future biologic analysis.
  OUTLINE: This is a multicenter study.
  Previously archived tumor samples are analyzed for p53 mutations and p16 deletion by immunohistochemistry, FISH, PCR, and DNA sequencing.

Eligibility: Inclusion Criteria:
  -  Diagnosis of Ewing sarcoma
  -  Banked specimens from patients enrolled on AEWS0031

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Biomarkers in Native American Women With Breast Cancer

Summary: RATIONALE: Studying samples of tumor tissue in the laboratory from Native American women with breast cancer may help doctors identify and learn more about biomarkers related to breast cancer in these patients. It may also help doctors learn more about the prognosis of these patients.
  PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast cancer.

Detailed description: OBJECTIVES:
  -  Evaluate a selected panel of molecular markers in tissue specimens from Native American women with breast cancer.
  -  Determine which molecular markers provide independent prognostic information with respect to traditional prognostic factors in these patients.
  -  Compare and contrast the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry.
  OUTLINE: Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of primary adenocarcinoma of the breast in Native American women
  -  Prior surgical treatment for breast cancer within the Aberdeen or Phoenix areas of the Indian Health Service or the Alaska area of the Native Health Service between 1990-2000
  -  Paraffin-embedded tissue available
  -  Paraffin-embedded tissue available from Caucasian women with breast cancer enrolled on NCCTG-77-30-51 or the Mayo Breast Cancer Registry
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Sex
  -  Female

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Tamoxifen Resistance in Women With Stage I, Stage II, Stage IIIA, or Stage IIIB Breast Cancer

Summary: RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors identify and learn more about biomarkers related to tamoxifen resistance.
  PURPOSE: This laboratory study is looking at tamoxifen resistance in women with stage I, stage II, stage IIIA, or stage IIIB breast cancer.

Detailed description: OBJECTIVES:
  -  Identify women who are resistant to tamoxifen citrate and other drugs for the treatment of breast cancer by testing their plasma for the presence of proteins (e.g., macrophage migration inhibition factor) encoded by resistance-inducing genes (RIGs).
  -  Provide retrospective data on the predictive value of RIGs to serve as the basis for a prospective clinical trial of these genes as predictors of drug resistance.
  OUTLINE: This is a multicenter study. Patients are stratified according to response during tamoxifen citrate (TAM) therapy (resistant group [i.e., those who develop recurrent breast cancer while being treated with TAM] vs conditionally sensitive group [i.e., those who have disease-free survival for over 3 years after initial diagnosis while being treated with TAM]).
  Patients undergo blood collection at baseline, within 3 weeks of initiation of TAM therapy, and then every 6 months for 3 years or until relapse, whichever comes first. Samples are analyzed by enzyme-linked immunosorbent assay for expression of protein biomarkers (i.e., kallikrein gene 10, macrophage migration inhibition factor, prolyl carboxypeptidase, queuine tRNA-ribosyltransferase, and kinesin) encoded by resistance-inducing genes. An additional blood sample is obtained from patients at the time of relapse, if available.
  Patients also undergo assessment of medical history, personal habits, and characteristics of breast cancer (e.g., tumor histology, stage, and grade) at baseline.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed invasive breast cancer
  -  Initial pathologic stage I-IIIB disease
  -  No stage IV disease
  -  Meets the following criteria for breast cancer therapy:
  -  Received prior primary local therapy for breast cancer
  -  Scheduled to begin tamoxifen citrate as adjuvant therapy for breast cancer within 3 weeks
  -  Hormone receptor status:
  -  Estrogen-receptor positive tumor
  -  Female
  -  Pre- or post-menopausal
  -  Must be able to donate 20 mL of blood
  Exclusion Criteria:
  -  Severe anemia, defined as hemoglobin < 11 g/dL
  -  Psychiatric history that would preclude obtaining informed consent

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Nutrition-Related Biomarkers in Predicting Breast Cancer Risk in Women

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about nutrition-related changes that identify biomarkers related to cancer. It may also help doctors predict a woman's risk of developing breast cancer.
  PURPOSE: This laboratory study is looking at nutrition-related biomarkers in predicting breast cancer risk in women.

Detailed description: OBJECTIVES:
  -  To complete characterization of metabolic serotypes based on the metabolome, and to adapt these profiles for human epidemiological studies.
  -  To determine the extent to which metabolic profiles that are reflective of or independent of long-term caloric intake predict breast cancer risk in nested case-control studies.
  -  To identify critical serum metabolites.
  OUTLINE: Laboratory studies, including metabolome profiling by high performance liquid chromatography; and small molecule identification by mass spectroscopy, are performed on previously collected blood samples.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Confirmed breast cancer that was diagnosed at least 2 years after blood sample collection (case)
  -  No prior diagnosis of cancer
  -  Healthy participant (control)
  -  Enrolled in the Nurses' Health Study
  -  Banked blood samples available
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer

Summary: The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.


Eligibility: Inclusion Criteria:
  -  Informed consent
  -  Age 60 years or older
  -  Measurable non-metastatic and non-inflammatory breast cancer
  -  Tumor of 2 cm or larger
  -  ER and/or PgR positive tumor
  -  Co-morbidity index 0 - 3, e.g., no other serious medical condition
  Exclusion Criteria:
  -  Prior medical therapy for a malignant disease, including aromatase inhibitors
  -  Distant metastasis
  -  Need for chemotherapy
  -  Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri)
  -  Treatment with a non-approved drug within 30 days

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

Summary: This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.

Detailed description: PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph node metastases. III. To evaluate the incidence of lymphedema and associated other surgical related quality of life in those undergoing this procedure as compared to the current standard of care.
  OUTLINE: This is a phase I study followed by a randomized phase II study.
  PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection.
  RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
  After completion of study treatment, patients are followed up periodically.

Eligibility: Inclusion Criteria:
  - Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer
  Exclusion Criteria:
  -  Prior lymphedema in either arm
  -  Prior history of axillary surgery (except for sentinel node biopsies)
  -  Prior history of chest/axillary radiation
  -  Need for bilateral axillary node dissection surgery
  -  Prior neurologic deficits (either motor or sensory) in ipsilateral arm
  -  Known allergy to vital blue dyes
  -  No prior diagnosis of inflammatory breast cancer
  -  Cannot be pregnant or planning to continue breast-feeding immediately after surgery

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine hydrochloride, epirubicin hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given together with epirubicin hydrochloride or docetaxel in treating patients with advanced or metastatic pancreatic cancer.
  PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin, capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel and to see how well it works in treating patients with stage III or stage IV pancreatic cancer.

Detailed description: OBJECTIVES:
  -  Assess 6-months progression-free survival of patients with stage III or IV adenocarcinoma of the pancreas treated with cisplatin, capecitabine, gemcitabine hydrochloride (PXG) and epirubicin hydrochloride vs PXG and docetaxel.
  -  Evaluate the activity and toxicity of these regimens in these patients.
  OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
  -  Arm I (PEXG): Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  -  Arm II (PGDX): Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  Patients may then undergo surgery if the tumor becomes resectable.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the pancreas
  -  Stage III or IV disease
  -  Measurable disease
  -  No symptomatic brain metastases
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 60-100%
  -  Adequate bone marrow, liver, and kidney function
  -  Not pregnant or nursing
  -  No other malignancies within the past 5 years except surgically treated carcinoma in situ of the cervix, and basal or squamous cell carcinoma of the skin
  -  No multiple severe diseases that can compromise study safety, including any of the following:
  -  Cardiac failure
  -  Myocardial infarction within the past 4 months
  -  Cardiac arrhythmia
  -  History of psychiatric disabilities
  PRIOR CONCURRENT THERAPY:
  -  No prior chemotherapy or radiotherapy for pancreatic cancer
  -  No other concurrent experimental drugs

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Study of Blood Samples From High-Risk Postmenopausal Women Who Received Treatment on Breast Cancer Prevention Clinical Trials NSABP-P-1 or NSABP-P-2

Summary: RATIONALE: Studying the genes expressed in 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.
  PURPOSE: This research study is looking at blood samples from high-risk postmenopausal women who received treatment on breast cancer prevention clinical trials NSABP-P-1 or NSABP-P-2.

Detailed description: OBJECTIVES:
  Primary
  -  To identify genes associated with breast events (i.e., the occurrence of invasive breast cancer or ductal carcinoma in situ), in terms of single-nucleotide polymorphisms (SNPs) in a genome-wide association study, in Caucasian women at high risk of developing breast cancer who have received a selective estrogen receptor modulator (SERM) (i.e., tamoxifen or raloxifene) on the NSABP-P-1 OR NSABP-P-2 breast cancer prevention clinical trials.
  -  To determine the impact of CYP2D6 metabolizer status, which includes genotype and status of concurrent use of CYP2D6 inhibitors, on breast cancer events in participants receiving either tamoxifen or raloxifene.
  Secondary
  -  To explore whether multiple SNPs within a region are independently associated with a breast event.
  -  To explore whether there are interactions among SNPs that increase the risk for a breast event.
  -  To explore whether there is interaction of any SNPs identified in the primary objective with randomized treatment, in terms of the risk for a breast event.
  -  To identify rare variants that might affect estrogen-dependent expression of chromosomes (CTSO) 4 and 16 (ZNF423) and/or the relationship to BRCA1 expression.
  OUTLINE: Samples are stratified according to CYP2D6 genotype and CYP2D6 metabolizer status.
  DNA extracted from previously collected blood samples is analyzed in a genome-wide association study and compared with 2 control samples from patients who did not experience a breast event. DNA samples are used to identify and analyze single nucleotide polymorphisms.
  Also, exploratory analyses are conducted examining the impact of CYP2D6 metabolizer status on breast cancer events according to invasive vs non-invasive disease, ER status, PgR status, histologic type, and TMN stage.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Previously treated on the NSABP-P-1 Breast Cancer Prevention clinical trial
  -  Caucasian women that did or did not experience an invasive breast cancer or ductal carcinoma in situ (DCIS)
  -  At least 50 years of age at time of entry to P-1
  -  Previously treated on the NSABP-P-2 Breast Cancer Prevention clinical trial
  -  Caucasian women that did or did not experience an invasive breast cancer or DCIS
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Postmenopausal status
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer

Summary: The purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respect to etiology and estrogen receptor status and to realize its side-effects and cost of therapy.
  To do a comparative analysis of the results with evening primrose oil which is one of the first line management in benign breast disease.

Detailed description: Benign breast disease is frequently encountered in female patients, a significant proportion of who are premenopausal women. Established methods of treatment do not yield significant results. This is not only a social burden but also entails high economic cost. As such the quality of life of these patients is a matter of concern for both the patients and their families and to attending physicians. Reported effects of tamoxifen on benign breast disease in premenopausal non high risk patients are scarce. Moreover published data has not yet revealed association of estrogen receptors in different benign breast lesions.The variability of response and its relation with estrogen receptor status is still a field of active investigation.

Eligibility: Inclusion Criteria:
  -  Clinical, Radiographic and Histological diagnosis of Benign Breast Disease.
  -  Benign Breast disease amenable to hormonal therapy.
  Exclusion Criteria:
  -  Postmenopausal women.
  -  Premenopausal women with pregnancy or other contraindications to tamoxifen.
  -  Girls less than 16 years.
  -  Very large lesions which require surgery for cosmesis.
  -  High risk breast lesions like epitheliosis, atypia or atypical hyperplasia on histopathology or susceptible lesions prone to develop malignancy.
  -  Lesions like duct ectasia where hormone therapy is not likely to be of benefit.
  -  Inflammatory lesions which are amenable to antibiotic therapy or surgical drainage for treatment.
  -  Patients unwilling to undergo treatment.

Relevance to patient case: not relevant