araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Discerning Detection of Clinically Significant Prostate Cancer Using Magnetic Resonance Imaging-Guided Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy

Summary: Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of increasing the detection of detecting clinically significant prostate cancer (csPCa) while decreasing the detection of non-significant PCa. The goals and the objective of this study are as follows keeping this in mind.

Detailed description: In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of clinically significant prostate cancers (csPCa) compared with systematic transrectal ultrasound-guided prostate biopsy.
  Patients who full-fills all eligibility criteria and have provided written consent will be randomized to undergo MRI followed by biopsies (arm A) or TRUS transrectal biopsy (arm-B). Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list. The primary end point will be the comparison of detection rates csPCa between arm A and arm B. csPCa will be defined according to the Standards of Reporting for MRI-targeted Biopsy Studies (START) criteria for targeted biopsy Gleason Score ≥ 7 or maximum CCL ≥ 5 mm and the updated Epstein criteria for SB (Gleason score ≥ 7, PSA density ≥ 0.15, Gleason score ≥ 2 positive cores, and bilateral cancer). The secondary end points will be (1) comparison of the overall detection rate of PCa and csPCa between arm A MRI+ and arm A MRI-, (2) comparison in terms of pathologic results and (3) comparison of complication rates.

Eligibility: Inclusion Criteria:
  1. Males aged 18-75 years old
  2. PSA >1 ng/ml but <15 ng/ml
  3. Negative DRE
  4. Signed informed consent
  Exclusion Criteria:
  1. Previous prostate biopsy or prostate surgery
  2. Previous prostate mpMRI
  3. Contraindication to mpMRI: patients with pacemakers, defibrillators or other implanted electronic devices
  4. Patients in the Texas Department of Criminal Justice (prisoners)
  5. Patients with acute urinary symptoms including urinary retention and urinary tract infection

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combining mitomycin or porfiromycin with radiation therapy is more effective in treating patients with head and neck cancer.
  PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus either mitomycin or porfiromycin in treating patients with head and neck cancer.

Detailed description: OBJECTIVES: I. Compare the efficacy of mitomycin vs. porfiromycin as an adjunct to radiotherapy for the treatment of epidermoid carcinomas of the head and neck.
  OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Irradiation of involved head and neck sites by external-beam radiotherapy (EBRT) alone (source not specified), brachytherapy alone (using permanent or removable radiation sources), or both; plus Mitomycin, MITO, NSC-26980. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Radiotherapy as in Arm I; plus Porfiromycin, NSC-56410.
  PROJECTED ACCRUAL: Approximately 200 patients will be entered over 3-4 years.

Eligibility: DISEASE CHARACTERISTICS: Biopsy-proven epidermoid carcinoma of the following head and neck sites: Hypopharynx Oral cavity Larynx Oropharynx Nasopharynx Unknown primary origin with positive head and neck nodes TNM Stages I-IV or recurrent disease with no distant metastases, i.e.: T1 N0 M0 T1 N1-3 M0 T2-4 any N M0 T0 N1-3 M0 No carcinoma of the true vocal cord or other condition with greater than 90% probability of cure
  PATIENT CHARACTERISTICS: Age: 20 to 80 Performance status: Not specified Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hct at least 25% Hepatic: Bilirubin less than 1.5 mg/dl Renal: Creatinine less than 2 mg/dl OR BUN less than 40 mg/dl Other: No other serious, life-threatening illness No second malignancy within 5 years except nonmelanomatous skin cancer outside the planned radiotherapy field
  PRIOR CONCURRENT THERAPY: At least 3 years since chemotherapy No prior radiotherapy to areas of current disease

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer

Summary: RATIONALE: Giving fluconazole may be effective in preventing or controlling mucositis caused by radiation therapy to the head and neck.
  PURPOSE: Randomized phase II/III trial to study the effectiveness of fluconazole in preventing mucositis in patients undergoing radiation therapy for head and neck cancer.

Detailed description: OBJECTIVES:
  -  Determine the effect of prophylactic antifungal therapy with fluconazole on the incidence and severity of radiation-associated mucositis/thrush in patients with head and neck cancer undergoing definitive radiotherapy.
  OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo standard hyperfractionated radiotherapy 5 days a week for 5-5.6 weeks. Patients receive oral fluconazole on days 1-4 and 28-31 of radiotherapy.
  -  Arm II: Patients undergo radiotherapy as in arm I. Patients who develop a microbiologically proven fungal infection or clinically evident oral cavity and/or oropharyngeal thrush may receive fluconazole as in arm I.
  PROJECTED ACCRUAL: At least 42 patients (26 per arm) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven head and neck cancer undergoing definitive radiotherapy
  PATIENT CHARACTERISTICS:
  Age:
  -  Over 21
  Performance status:
  -  Karnofsky 70-100%
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  SGOT and SGPT less than 2 times normal
  -  Alkaline phosphatase less than 2 times normal
  Renal:
  -  Not specified
  Other:
  -  No history of hypersensitivity to fluconazole
  -  HIV negative
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified
  Other
  -  At least 2 months since prior antifungal agents
  -  Not currently receiving phenytoin, hydrochlorothiazide, or warfarin
  -  If these medications are initiated during study therapy, medication serum levels and electrolytes are monitored for possibility of drug interaction

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Gene Therapy in Treating Patients With Cancer

Summary: RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill cancer cells.
  PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy.

Detailed description: OBJECTIVES:
  -  Determine the safety and maximum tolerated dose of T cells activated in vitro and modified with chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR) in patients with CEA expressing adenocarcinoma.
  -  Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients.
  -  Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR.
  -  Assess immunologic parameters which correlate with the efficacy of this regimen in these patients.
  -  Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumors.
  OUTLINE: This is a dose escalation study.
  Peripheral blood lymphocytes (PBL) are harvested. PBL are activated in vitro and then modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR). Ig TCR modified T cells are reinfused over 30-60 minutes.
  The estimated maximum tolerated dose (MTD) is defined as the dose at which 2 of 6 patients experience unacceptable toxicity. If the MTD is not reached within the first cohort, a second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose.
  Patients are followed every 2 weeks for 2 months.
  PROJECTED ACCRUAL: A total of 6-9 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven CEA expressing adenocarcinoma
  -  Serum CEA levels greater than 10 ng/mL
  -  Failed standard therapy
  -  Measurable disease
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  0-2
  Life expectancy:
  -  Greater than 2 months
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  No significant hepatic disease
  -  Bilirubin no greater than 3 mg/dL
  -  No active clinical disease caused by hepatitis B
  Renal:
  -  No significant renal disease
  -  Creatinine no greater than 3 mg/dL
  Cardiovascular:
  -  No significant cardiovascular disease
  Pulmonary:
  -  No significant pulmonary disease
  Other:
  -  Not pregnant
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No significant endocrine, rheumatologic, or allergic disease
  -  No active clinical disease caused by cytomegalovirus or tuberculosis
  -  HIV negative
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  At least 4 weeks since prior chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  At least 4 weeks since prior radiotherapy
  Surgery:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining radiation therapy and tamoxifen with surgery may kill more tumor cells. It is not yet known which treatment regimen is most effective for stage I breast cancer.
  PURPOSE: Randomized phase III trial to compare the effectiveness of four different treatment regimens in treating women who have stage I breast cancer.

Detailed description: OBJECTIVES: I. Compare the effectiveness of wide local excision alone versus wide local excision followed by radiotherapy with or without tamoxifen versus wide local excision plus tamoxifen in women with stage I breast cancer. II. Assess local occurrence in the treated breast, regional recurrence, distant recurrence, death from breast cancer, and occurrence of cancer in the opposite breast in these patients when treated with one of these regimens.
  OUTLINE: This is a randomized study. Patients are randomized to one of four treatment arms. All patients undergo wide local excision of the tumor and axillary node dissection. Arm I: Patients undergo surgery only. Arm II: Patients undergo surgery followed by 25-35 radiotherapy treatments. Arm III: Patients undergo surgery plus oral tamoxifen daily for 5 years. Arm IV: Patients undergo surgery followed by 25-35 radiotherapy treatments and oral tamoxifen daily for five years. Patients are followed every 3 months for 2 years, and then every 6 months thereafter.
  PROJECTED ACCRUAL: A total of 1200 patients (300 per treatment arm) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed unilateral stage I invasive breast cancer No more than 1 tumor and no greater than 2 cm Grade 1 tumor of any histological type OR No special type OR Mixed type allowed No lymph node involvement No in situ carcinoma only or ductal carcinoma in situ with microinvasion No vascular invasion No Paget's disease of the nipple Well differentiated special type of primary mammary carcinoma including: Tubular Tubular/cribriform Cribriform Papillary Mucoid No lobular, medullary, or other rarer types of mammary carcinomas including: Adenoid cystic Carcinoid Secretory Spindle cell Apocrine No distant metastases Hormone receptor status: Not specified
  PATIENT CHARACTERISTICS: Age: Under 70 Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No other systemic disease that may preclude study No other prior malignancy except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  PRIOR CONCURRENT THERAPY: No other concurrent adjuvant systemic therapy

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Boron Neutron Capture Therapy in Treating Patients With Melanoma

Summary: RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.
  PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have melanoma.

Detailed description: OBJECTIVES:
  -  Determine the clinical response, by serial objective measurements, in patients with melanoma treated with boron neutron capture therapy.
  -  Determine the time course, uniformity, and severity of acute dermal reactions in patients treated with this regimen.
  -  Determine the late dermal reactions in patients who are followed for at least 6 months after treatment with this regimen.
  -  Determine the pharmacokinetics of this regimen in these patients.
  OUTLINE: Patients are stratified according to tumor size (no greater than 15 cc vs greater than 15 cc).
  Patients undergo boron neutron capture therapy.
  Patients are followed for 3 years.
  PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed melanoma
  -  Evaluable disease
  -  Lesion(s) to be irradiated must be located in 1 of the following areas:
  -  On an extremity
  -  On the head or neck (including the scalp)
  -  In the subdermal lymphatics (excluding the proximal axilla)
  -  Area to be irradiated must not exceed a maximum dimension of 10 cm
  -  Maximum tumor depth from the surface of the skin cannot exceed 6 cm
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  ECOG 0-1
  Life expectancy
  -  More than 6 months
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Creatinine normal
  Cardiovascular
  -  No history of severe cardiac disease
  -  No uncontrolled arrhythmias or conduction defects
  -  No unstable or newly diagnosed angina pectoris
  -  No recent coronary artery disease
  -  No congestive heart failure
  Other
  -  Not pregnant
  -  Negative pregnancy test
  -  No history of phenylketonuria
  -  Must have sufficient mental competence
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  No prior radiotherapy to study sites
  Surgery
  -  Not specified

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases

Summary: Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine kinases, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease.


Eligibility: Inclusion Criteria:
  -  Patients ≥ 15 years of age
  -  Life threatening disease documented by conventional criteria to be resistant to standard, approved therapy.
  -  Experimental documentation of functional significance of either Abl, Kit (CD117), or PDGF-R in the relevant target tissue (preferably on a sample taken within 6 weeks of study entry).
  -  ECOG Performance status of 0, 1, or 2.
  -  Adequate end organ function defined as: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN for patients with hepatic disease), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L.
  -  Negative serum or urine pregnancy test for women of child bearing potential (WOCBP) within 7 days of study initiation. Post menopausal women must have experienced amenorrhea for at least 12 months. Male and female patients must use effective birth control methods throughout the study and for up to 3 months after study discontinuation.
  -  Life expectancy of more than 3 months.
  -  Written, voluntary, informed consent for retrieval, evaluation and investigational use of tissue samples.
  Exclusion Criteria:
  -  Patients who have received any other investigational agent within 28 days of study initiation.
  -  Patients with another primary malignancy except if other primary malignancy is neither currently clinically significant nor requiring active intervention.
  -  Patients with Grade III/IV cardiac problems defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study).
  -  Female patients who are pregnant or breast-feeding.
  -  Patients who have another severe and/or life threatening medical disease.
  -  Patients with acute or known chronic liver disease (e.g. chronic active hepatitis, cirrhosis).
  -  Patients with a known diagnosis of the human immunodeficiency virus ((HIV) infection.
  -  Patients who have received chemotherapy within 4 weeks (6 weeks allowed for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry.
  -  Patients who have had major surgery within 2 weeks prior to study entry.
  -  Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Role of Glivec in Patients With Tumor Cells Positive for C-kit or PDGFR; a Multi Center Study.

Summary: This is a phase II, multi-center (Israeli), open label, non-randomized trial for every patient with the specified tumors expressing c-kit or PDGFR. Expression of these kinases will be investigated in tumor samples obtained at the time of diagnosis or from the time of recurrent disease. Every patient with positive expression of either of the kinases will be evaluated for quantitative and qualitative evidence of disease prior to entry into the study, and if possible, no other treatment will be given concomitantly, to allow evaluation of the net effect of Glivec on tumor growth kinetics, searching for measurable evidence of response.
  Glivec is supplied to the study investigators by Novartis Pharmaceutical. Patients will receive Glivec 400mg-800mg p.o./day for an exposure period of up to 12 months provided that in the opinion of the investigator the patient is benefiting from treatment with Glivec, and in the absence of any safety concern. For patients with brain tumors who are not receiving concomitant enzyme inducing anti-convulsant drugs, the recommended dose of Glivec is 800mg/day.


Eligibility: Inclusion Criteria:
  -  Patients > 18 years of age.
  -  Histologically documented diagnosis of one of the specified tumors, which is malignant as well as unresectable and/or metastatic and therefore, incurable with any conventional multimodality approach and immunohistochemical documentation of c-kit (CD117) or PDGFR expression in the primary tumor or metastases by tumor (preferably on a tumor sample taken within 6 week of study entry).
  -  At least one measurable site of disease as defined by Southwestern Oncology Group Solid Tumor Response Criteria.
  -  Female patients of child-bearing potential must have negative pregnancy test.
  -  Signed informed consent form.
  -  Life expectancy >3 months.
  Exclusion Criteria:
  -  Patient has received any other investigational agents within 28 days of the first day of study drug dosing.
  -  Existence of any evidence of another malignant disease, except superficial non-melanoma skin cancer.
  -  Patient has a known brain metastases.
  -  Patient previously received radiotherapy to >25% of the bone marrow.

Relevance to patient case: possibly relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease

Summary: The researchers are investigating a novel technique, the multi breath nitrogen washout technique, to measure airway changes in various respiratory diseases.

Detailed description: It is well documented that there are significant ventilatory changes in respiratory diseases such as cystic fibrosis, asthma and the onset of bronchiolitis obliterans syndrome (BOS) following chronic rejection of lung transplantation. At present, we use measures such as spirometry and lung biopsies to determine the changes of airway function and disease severity. Our aim is to develop a novel technique called the multi breath nitrogen washout (MBNW) which we believe is able to measure the inhomogeneity of ventilation in both the larger airways (conductive region, generation 1 - 16) as well as the smaller airways (acinar region 17 - 23). Our belief is that these measurements are much more subtle than current techniques and will be more sensitive in measuring large and small airway changes in disease. The MBNW can also give us an insight as to which particular zones of the lung are affected in differing respiratory disease. For example, it is believed that BOS begins at the distal portion of the lung (acinar region) and proceeds towards the proximal zone (conductive). However, at present no current techniques can differentiate between damage to the acinar zone and the conductive zone or indeed accurately measure small airway (acinar zone) function. We believe the the MBNW has the capacity to do so.

Eligibility: Inclusion Criteria:
  -  Doctor diagnosed cystic fibrosis, asthma
  -  Lung transplant recipient
  Exclusion Criteria:
  -  Smoke history of less than 10 pack years

Relevance to patient case: not relevant