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

Clinical trial: Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women

Summary: RATIONALE: Studying mammograms for breast density changes over time may help doctors predict breast cancer risk.
  PURPOSE: This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

Detailed description: OBJECTIVES:
  -  Characterize each woman's individual mammographic density (MD) longitudinal change trajectory in women with breast cancer and in healthy female participants to assess within-individual MD longitudinal change and breast cancer risk.
  -  Examine whether these patients or healthy participants manifest different patterns of within-individual change in MD and evaluate predictors of across-individual differences.
  -  Determine whether the developmental profile of MD differs systematically between these patients and healthy participants.
  OUTLINE: This is a prospective, retrospective, controlled study. Patients and healthy participants are frequency-matched by age (± 2 years) and ethnicity.
  -  Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
  -  Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
  PROJECTED ACCRUAL: A total of 1500 patients and 1500 healthy participants will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system
  -  Have at least 3 screening mammograms since 1994
  -  for cases, diagnosis with breast cancer between 2004-2006
  Exclusion criteria:
  -  having had irregular screening (less than 3 mammorgrams since 1994)
  -  Having breast implants
  -  Known carriers of BRCA1/BRCA2 genes
  -  Unable to give written consent

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

Clinical trial: A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

Summary: The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.


Eligibility: Inclusion Criteria:
  Inclusion criteria for both parts of clinical trial:
  -  Good performance status
  -  Normal ejection fraction
  -  Adequate cardiac, kidney, and liver function
  -  Adequate blood counts
  -  At least one measurable target lesion
  -  Negative pregnancy test for female subjects
  Inclusion Criteria for Part 1 Only:
  - Pathologically confirmed solid tumor not curable with available standard therapy
  Inclusion Criteria for Part 2 Only:
  -  Pathologically confirmed breast cancer
  -  HER2 positive tumor
  -  Prior treatment with Herceptin
  Exclusion Criteria:
  Exclusion criteria for both parts of clinical trial:
  -  Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1
  -  Subjects with bone or skin as the only site of disease
  -  Active central nervous system metastases
  -  Significant cardiac disease or dysfunction
  -  Significant gastrointestinal disorder
  -  Inability or unwillingness to swallow HKI-272 capsules
  -  Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.
  -  Treatment with a taxane within 3 months of treatment day 1
  -  Grade 2 or greater motor or sensory neuropathy
  -  Pregnant or breast feeding women
  -  Known hypersensitivity to paclitaxel or Cremophor EL
  -  Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2
  -  Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
  Exclusion Criteria for Part 2 Only:
  - More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease

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

Clinical trial: Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters

Summary: RATIONALE: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future.
  PURPOSE: This study is collecting blood samples and health information over time from patients with invasive breast cancer and from their brothers and sisters.

Detailed description: OBJECTIVES:
  -  Collect blood samples and medical and background information from patients with invasive breast cancer and their affected or unaffected siblings.
  OUTLINE: Patients and their siblings undergo blood collection. They also complete medical and background questionnaires.
  Patients and their siblings are followed annually for 5 years.
  PROJECTED ACCRUAL: A total of 1,000 patients and siblings will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Pathologically confirmed invasive breast cancer (patient)
  -  No ductal carcinoma in situ
  -  Affected OR unaffected sibling
  -  Affected sibling must have had (or currently has) breast cancer only
  -  Unaffected sibling must be female
  -  No deceased siblings
  -  Must be a full-blood related sibling
  -  Patients receiving treatment on clinical trial ECOG-E1Y97 or ECOG-E3Y92 are not eligible
  PATIENT CHARACTERISTICS:
  -  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: Study of Families With Melanoma

Summary: RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse.
  PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.

Detailed description: OBJECTIVES:
  Primary
  -  Determine what lifestyle factors and which genes govern relapse from melanoma.
  Secondary
  -  Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants.
  -  Assess how unusual moles relate to sun exposure and genes that cause melanoma.
  OUTLINE: This is a multicenter, cohort study.
  Patients and healthy participants complete lifestyle questionnaires by mail and telephone. Some patients* and healthy participants undergo a skin examination to count moles and classify skin type (e.g., degree of freckling and wrinkling indicative of sun damage).
  NOTE: *Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination.
  Patients and healthy participants also undergo blood collection for lymphocyte analysis, DNA extraction, and the measurement of minerals, vitamins, and beta carotene. Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations, including CDKN2A and CDK4.
  Patients and healthy participants are followed annually.
  Peer reviewed and funded or endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 3,700 patients and healthy participants will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Newly diagnosed primary invasive melanoma (patient group)
  -  Lentigo maligna malignant melanoma allowed
  -  Rare variants of melanoma allowed, including any of the following:
  -  Acral lentiginous
  -  Subungual
  -  Ear, nose, and throat
  -  Oropharyngeal
  -  Perineal
  -  Vaginal
  -  Vulval
  -  Rectal
  -  Nodal with no known primary
  -  Patients undergoing sentinel node biopsy are eligible
  -  No in situ melanoma, melanocytic intraepidermal neoplasia, or ocular melanoma
  -  Healthy participant meeting either of the following criteria (control group):
  -  Relative of a patient who was diagnosed with melanoma after September 2005
  -  Healthy volunteer who is age- and sex-matched for patients who were diagnosed with melanoma before October 2005
  PATIENT CHARACTERISTICS:
  -  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: Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs

Summary: The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study.

Detailed description: This is a community-based case-control study in Germany and Finland. Cases will be identified from cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from. Breast cancer cases and their controls are women under 50 years of age without known history of malignancies.
  Cases are women with a breast cancer who are younger than 50 years of age at cancer diagnosis. The breast cancer was diagnosed between January 2000 and December 2007. Only alive cases and cases in a sufficiently good health status to be interviewed are eligible for the study.
  Controls are women without a breast cancer diagnosis who are younger than 50 years of age at the time of the interview. About 3 controls matched by year of birth and region will be allocated to each case.
  A standardized questionnaire will be used for all breast cancer cases and controls. The questionnaire will be mailed to cases and controls.
  Study participants will be asked for their informed consent. Data confidentiality according to national laws will be ensured by the field organizations.

Eligibility: Inclusion Criteria:
  -  cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis
  -  controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview
  Exclusion Criteria:
  -  women who are not willing to participate

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

Clinical trial: High Risk Breast Cancer Screening Program

Summary: Objectives:
  -  To screen population with high risk for breast cancer
  -  To promote the concept and importance of surveillance mammography
  -  To find out the incidence of breast cancer in population who are in high risk for breast cancer
  -  To collect blood samples for molecular analysis


Eligibility: Inclusion Criteria:
  -  Female
  -  > 40 years of age
  -  Women who have first-degree relative suffered from breast cancer
  -  Women who have first-degree relative suffered from ovarian cancer
  -  Family history of male breast cancer
  -  Family history of breast cancer (not necessarily first degree relatives) diagnosed before age of 40
  -  Family history of breast cancer (not necessarily first degree relatives) affecting 2 or more family members
  -  Personal history of ovarian cancer
  -  Personal history of premalignant conditions of breast and ovary
  Exclusion Criteria:
  -  Women with mammogram within one year

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

Clinical trial: Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy

Summary: Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.

Detailed description: The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues.
  Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.
  There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.

Eligibility: Inclusion Criteria:
  -  Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
  -  Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy
  Exclusion Criteria:
  -  Female pregnant and age less than 21 years old and have no diagnosis of breast cancer

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

Clinical trial: Genetic Studies in Breast Cancer

Summary: The purpose of this study is to determine the specific genetic alterations associated with breast cancer. This will leat to a better understanding of the genetic causes of breast cancer.

Detailed description: It is estimated that 175,000 new breast cancer cases and 44,5000 cancer deaths will result from female breast cancer in 1991. One of the most important risk factors is a family history of breast cancer. A susceptibility allele which accounts for a large proportion of familial breast cancer has been localized to chromosome 17q and attempts to clone the susceptibility are proceeding rapidly. The existence of recognized susceptibility loci and the awareness of a significan proportion of genetic predisposition and the associated penetrances remain unknown and are impossible to estimate without bias from previous studies. This study is designed to estimate heterogeniety and prenetrance in a series of unslected families, identify additional breast cancer susceptibility locs, as well as provide resources for gene isolation and mutation analysis studies.

Eligibility: Inclusion Criteria:
  -  patient with breast cancer under age 41
  -  patient with bilateral breast cancer 41-50 years old or 41-50 years old with a first degree relative (mother, sister, daughter) with breast cancer diagnosed under age 50
  -  patient with ovarian cancer with first degree relative with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 60
  -  patient any age with either ovarian or breast cancer who have 2 first degree rleatives with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 50
  -  relatives of any of the above patients will be included in this trial if a genetic abnormality is found in the patient's blood sample
  Exclusion Criteria:

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

Clinical trial: Korean Hereditary Breast Cancer Study

Summary: 1. To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients with family history of breast/ovarian cancer.
  2. To evaluate the prevalence of BRCA1/2 mutation of breast cancer patients without family history, but high risk of hereditary cancer.
  3. To evaluate the prevalence of BRCA1/2 mutation of family member of BRCA1/2 mutation.
  4. To evaluate the prevalence of ovarian cancer of population of above 3 groups.

Detailed description: 1. To find founder mutation in Korean
  2. To correlation prevalence with risk evaluation
  3. To find risk factors concerning life style

Eligibility: Inclusion Criteria:
  -  Over 19 years old
  -  Agree to this study
  -  Breast cancer patient with family history of breast/ovarian cancer (1 subgroup)
  -  Breast cancer patient; young age (<40), bilateral, male, combined ovarian (2 subgroup)
  -  Family members with 1, 2 subgroups (3 subgroup)
  Exclusion Criteria:
  -  Under 20 years old
  -  Unable to decide for oneself

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

Clinical trial: Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

Summary: This study will investigate whether adding the optical imaging to magnetic resonance imaging can improve the diagnostic specificity of breast cancer.


Eligibility: Inclusion Criteria:
  1. A female older than 21 years of age,
  2. Have suspicious imaging findings suggesting a possibility of breast cancer, or biopsy-proven breast cancer.
  Exclusion Criteria:
  1. Pregnant,
  2. Unwilling to give informed consent,
  3. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
  4. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
  5. Have received orthodontic work involving ferromagnetic materials,
  6. Claustrophobic,
  7. Have had allergic response to contrast agents (such as iodine or gadolinium) previously,
  8. Have known history of severe renal insufficiency, asthma, allergic conditions, sickle cell anemia, chronic hemolytic anemia, and gastrointestinal disorders.

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

Clinical trial: Sensory Morbidity Following Breast Surgery

Summary: The goal of the study is measure breast sensations after breast surgery. The results of this study will help surgeons better understand breast sensations and may improve the way surgery is done.


Eligibility: Inclusion Criteria:
  -  The Samples used will be derived from three cohorts below and will only include patients who have completed mastectomy or reconstruction within 1-5 years of enrollment.
  -  Patients who have undergone immediate, two-stage expander/implant postmastectomy reconstruction
  -  Patients who have undergone immediate, autogenous tissue flap reconstruction following mastectomy
  -  Patients who have undergone mastectomy alone
  -  Patients at least 21 years of age
  -  Patients who completed mastectomy ± immediate post-mastectomy reconstruction at least one year but no longer than five years prior to study entry
  Exclusion Criteria:
  -  Patients who have had any of the following:
  -  delayed reconstruction (no reconstruction at time of surgery) combined autogenous tissue/implant breast reconstruction, and/or
  -  Patients who have a pre-surgical history of complex regional pain syndrome
  -  Patients who have had radiation therapy
  -  Patients who have had a local recurrence
  -  Patients who do not speak the English language (validated translations of key questionnaires are not available).

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

Clinical trial: Second Line Breast Cancer Trial

Summary: The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.


Eligibility: Inclusion Criteria:
  -  postmenopausal women with confirmation of breast cancer
  -  objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer
  Exclusion Criteria:
  -  presence of life-threatening metastatic visceral disease
  -  previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
  -  more than 1 prior endocrine medical treatment for advanced breast cancer .

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

Clinical trial: Early Detection of Breast Cancer Using Tomosynthesis Imaging

Summary: The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.

Detailed description: Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.

Eligibility: Inclusion Criteria:
  All Subjects accepted for this clinical study must:
  -  Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications
  -  Provide written informed consent
  -  Be able to communicate effectively with clinical study personnel.
  Exclusion Criteria:
  Subjects with any of the following conditions will be excluded from this clinical study:
  -  Childbearing potential and subject refuses serum pregnancy test or test result is positive.

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

Clinical trial: Nipple Areola Complex Conservation

Summary: 96 patients were offered a nipple sparing mastectomy.

Detailed description: 96 patients were operated on 109 breasts between Jul 2003 and May 2006 because of breast cancer, recurrence was observed.

Eligibility: Inclusion Criteria:
  -  breast cancer
  Exclusion Criteria:
  -  inflammatory breast cancer
  -  clinical skin or nipple involvement

Relevance to patient case: not relevant