araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Cisplatin, Carboplatin, Oxaliplatin, Docetaxel and Gemcitabine Plus Surgery for Recurrent Non-Small Cell Lung Cancer

Summary: The purpose of this study is to determine if the commonly administered chemotherapeutic agents including cisplatin, carboplatin, oxaliplatin, docetaxel and gemcitabine for solid tumors in clinical oncology, either a single format or given as combinations followed by surgery are effective in the treatment of relapsed and refractory non-small cell lung cancer patients.

Detailed description: Lung carcinoma is a malignant disease characterized by uncontrolled alveolar type II epithelial cell growth in lung tissues. Worldwide in 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths, making it the most common cause of cancer-related death in men and second most common in women after breast cancer. The most common age at diagnosis is 70 years, and less than 20% of people diagnosed with lung cancer can survive five years post diagnosis. The two main types of lung carcinomas are small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC). NSCLC represents the most common type of lung cancers, and approximately 85% of lung cancers are NSCLC. Squamous cell carcinoma, adenocarcinoma, and large cell carcinoma are all subtypes of NSCLC, the latter associated with high mortality in overall cancer populations with limited treatment options.
  In this study, the investigators performed a Phase I, open label, agent-combination exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with recurrent NSCLC who have undergone prior surgery for the primary disease. Up to four cohorts have been enrolled to determine the effectiveness and safety of single or combinational therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.

Eligibility: Inclusion Criteria:
  -  Age ≤ 75 years with histologically proven NSCLC
  -  No severe major organ dysfunction
  -  WHO performance status of 0 or 1
  -  No prior cancer chemotherapy
  -  A Clinical Stage ≥ IA (T1a, N0, M0) of lung disease but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan.
  Exclusion Criteria:
  -  Age ≥ 76
  -  Severe major organ dysfunction
  -  WHO performance status of >1
  -  Prior cancer chemotherapy
  -  Stage IV

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo

Summary: The purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.


Eligibility: Inclusion Criteria:
  -  Subjects currently working at the Local Health Authority of the province of Bergamo
  Exclusion Criteria:
  -  Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: NANOTECH RCC Biomarkers

Summary: The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia, ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study focuses on identifying specific molecules [biomarkers] of RCC that can be used to develop a reliable low-cost screening method at the point of service. If successful, our method would provide a diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need to surgically remove a kidney with a benign tumor.


Eligibility: Inclusion Criteria:
  Patients 18 years of age and older undergoing surgery. Patient samples are divided into 2 groups based on their surgery: Patients with an imaged renal mass, encompassing about 300 patients/year (about 1200 total) of both malignant (about 80-85% of time) and benign (about 15-20% of time), and patients with non-kidney cancers, encompassing about 6,000 patients/year (about 24,000 total),
  Exclusion Criteria:
  Age <18 years and prisoners.

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Acquisition of 3D Facial Geometry of Patients' Scheduled for Radiotherapy Treatment

Summary: This study investigates the feasibility of using 3D-Printing to manufacture masks used to immobilize patients undergoing radiotherapy treatment for tumors affecting the head and neck.

Detailed description: The current types of masks that are used in radiotherapy treatment sessions for those patients who have head-and-neck cancer are 'made to measure' and the methods currently employed to make them are invasive and in some cases patients' have found this to be particularly unpleasant. Their experience motivates research into less invasive and potentially more accurate techniques for their manufacture.
  To effectively develop an automatic manufacturing pipeline, and to assess the accuracy of the approach we need access to CT data from a cohort of patients for which we also have an accurate (ground truth) 3D facial model. Such a model can be acquired in a few minutes using a hand-held laser scanner.

Eligibility: Inclusion Criteria:
  -  Have a Head-and-neck cancer
  -  Receiving radiotherapy treatments (CT images)
  Exclusion Criteria:
  -  Children (age less than 18)

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

Summary: A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy


Eligibility: Inclusion Criteria:
  -Histologically or cytologically confirmed unresectable locally advanced NSCLC with progressed or recurred after no more than four previous docetaxel-free chemotherapy regimens, or unresectable locally advanced or metastatic SCCHN or recurred after previous docetaxel-free chemotherapy regimens
  Exclusion Criteria:
  1. Women who are nursing or pregnant during the study period;
  2. Patients with carcinoid tumors, small-cell carcinoma of the lung;
  3. A history of another malignancy within the last five years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the uterine cervix);
  4. Any other morbidity or situation with contraindications for chemotherapy (e.g. active infection, myocardial infarction in the preceding 6 months);
  5. Neutrophil counts < 1,500 cells/mm3;
  6. A history of hypersensitivity to docetaxel or cisplatin;
  7. Symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias;
  8. Subjects have active hepatitis;
  9. Subjects are known positive for Human Immunodeficiency Virus (HIV);
  10. Any condition judged by investigator, participates the study will jeopardize patient's wellbeing

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: A Trial of PT2977 Tablets In Patients With Advanced Solid Tumors

Summary: The primary objective of this study is to identify the maximum tolerated dose (MTD) of PT2977 Tablets and/or the recommended Phase 2 dose (RP2D) of PT2977 Tablets in patients with advanced solid tumors

Detailed description: Part 1A: This is a Phase 1, multiple-dose, dose-escalation trial of PT2977 Tablets, where patients with advanced solid tumors will be assigned to sequential dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, electrocardiograms (ECGs), and hematology and chemistry laboratory studies, and by recording all adverse events (AEs). Blood will be obtained for analysis of the concentration of PT2977 and to assess biomarkers.
  Part 1B: Once the MTD and/or the RP2D is achieved, and expansion cohort of 25 patients with advanced clear cell renal cell carcinoma (ccRCC) will be enrolled.
  Part 2: After determination of the MTD/RP2D, up to 25 patients with other specified solid tumors may be enrolled. Up to 3 different tumor types may be included in this part of the study.

Eligibility: Inclusion Criteria:
  -  Has a diagnosis of locally advanced or metastatic solid tumor
  -  Is of age ≥ 18 years
  -  Has a life expectancy of ≥ 3 months
  -  Has adequate organ function
  -  If a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
  -  Able to swallow oral medications
  Exclusion Criteria:
  -  Has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression
  -  Has failed to recover from the reversible effects of prior anticancer therapy
  -  Has uncontrolled or poorly controlled hypertension
  -  Has malabsorption due to prior gastrointestinal (GI) surgery or GI disease
  -  Has had any major cardiovascular event within 6 months prior to study drug administration
  -  Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
  -  Has had major surgery within 4 weeks before first study drug administration
  -  Has known HIV
  -  Has an active infection requiring systemic treatment
  -  Is participating in another therapeutic clinical trial

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

Summary: This 22 week study will assess the efficacy, safety, and tolerability of LDE225 versus vehicle when applied topically to basal cell carcinoma (BCC) in patients with NBCCS. Patients will treat multiple BCCs for up to 12 weeks. Treatment success is defined as complete clinical clearance and complete histological clearance in BCCs.


Eligibility: Inclusion Criteria:
  1. Adult greater than 18 years old, male or female.
  2. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study.
  3. Typical presentation of NBCCS in the opinion of the investigator
  4. At least one of the major clinical criteria of NBCCS.
  5. Multiple BCCs during the screening period
  Exclusion Criteria:
  1. Any concomitant dermatological disease that could confound the evaluations, based on the discretion of the investigator.
  2. Prior exposure to LDE225.
  3. Use of systemic treatment for BCC in the 4 weeks prior to Baseline.
  4. Use of topical treatment or photodynamic therapy (PDT) in the 12 weeks prior to Baseline.
  5. Use of other investigational drugs at Baseline, or within 30 days or 5 half-lives prior to Baseline, whichever is longer.
  6. Clinically significant medical condition, as per judgment of the investigator.
  7. History of hypersensitivity to any of the ingredient of the study drug.
  8. Pregnant or nursing (lactating) women
  9. Women of child-bearing potential and fertile males, UNLESS they are using two birth control methods
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

Summary: RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors.
  PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors, including astrocytoma, ependymoma, and medulloblastoma.

Detailed description: OBJECTIVES:
  -  Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy.
  -  Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes, and survival of these patients.
  OUTLINE: This is a dose-escalation study. Patients are stratified according to tumor location (posterior fossa tumors vs all other brain tumors).
  Patients receive benzoporphyrin monoacid ring A (BPD-MA) IV preoperatively. Approximately 3 hours after BPD-MA administration, patients undergo craniotomy with photoillumination of the tumor. Patients with tumors greater than 2 cm in diameter also undergo gross tumor resection.
  Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Three additional patients are treated at the MTD.
  Patients are followed at 4 and 6 weeks, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
  PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of supratentorial or infratentorial brain tumor
  -  Localized, non-disseminated
  -  Primary tumor or solitary metastasis
  -  Recurrent or progressive
  -  Unresectable
  -  Negative CSF
  -  Must have failed standard therapy including radiotherapy
  -  Measurable disease as evidenced by CT scan or MRI
  -  Single or multiple masses accessible to light administration
  PATIENT CHARACTERISTICS:
  Age:
  -  3 to 70
  Performance status:
  -  Not specified
  Life expectancy:
  -  At least 2 months
  Hematopoietic:
  -  Absolute neutrophil count at least 1,000/mm3
  -  May transfuse platelets
  Hepatic:
  -  PT and PTT normal
  Renal:
  -  Not specified
  Other:
  -  Not pregnant
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  At least 6 weeks since prior chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  See Disease Characteristics
  -  No prior brachytherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No other concurrent antitumor therapy

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Carboplatin in Patients With Progressive Gliomas

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of carboplatin in patients with progressive glioma.

Detailed description: OBJECTIVES: I. Assess the response to carboplatin (CBDCA) in patients with progressive low-grade gliomas. II. Assess the activity of CBDCA in stabilizing the growth of these tumors.
  OUTLINE: Single-Agent Chemotherapy. Carboplatin, CBDCA, NSC-241240.
  PROJECTED ACCRUAL: A total of 25 evaluable patients will be entered if there is at least 1 response in the first 9 patients.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed primary intracranial low-grade glioma (i.e., astrocytoma or oligodendroglioma) No more than 2 years since tissue diagnosis Biopsy not required for intrinsic chiasmatic mass or tumor infiltration along the posterior optic tracts Evidence of progressive disease by at least one of the following: Papilledema or other clinical sign of increased intracranial pressure Documented change in neuroimaging studies, e.g.: Hydrocephalus 25% increase in product of maximum perpendicular diameters of tumor The following are required in patients with optic pathway gliomas: Progressive loss of vision documented by an ophthalmologist, i.e.: Doubling of octaves (e.g., 20/20 to 20/40 or 20/40 to 20/80) on 2 successive visits Loss of visual acuity not explainable by other causes, e.g., media abnormalities or amblyopia Greater than 3 mm increase in proptosis At least 2 mm increase in diameter of optic nerve on neuroimaging Increase in distribution of tumor involving the optic tracts or optic radiations demonstrated by CT or MRI using T1 (with or without contrast) or T2 imaging
  PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70%-100% Life expectancy: At least 12 weeks Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin less than 1.5 times normal ALT less than 1.5 times normal Renal: Creatinine less than 1.5 mg/dL Other: Negative pregnancy test required of fertile women Effective contraception required of fertile patients
  PRIOR CONCURRENT THERAPY: At least 12 weeks since radiotherapy (4 weeks since other therapy) and recovered Prior chemotherapy allowed with subsequent disease progression

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with glioma. Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if standard radiation therapy is more effective when followed by stereotactic radiation therapy.
  PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with or without stereotactic radiation therapy in treating patients who have glioma.

Detailed description: OBJECTIVES: I. Compare the effect of adjuvant conventional radiotherapy with or without fractionated stereotactic boost radiotherapy on survival in patients with high grade glioma. II. Compare the quality of life of these patients after these therapies.
  OUTLINE: This is a randomized study. Patients are stratified according to WHO disease grade (III vs IV), center, and age (under 40 vs 40 and over). Patients are randomized to undergo stereotactic radiotherapy or no further treatment after conventional radiotherapy. Patients undergo conventional radiotherapy once or twice a day for up to 6 weeks. Patients randomized to receive additional treatment receive stereotactically guided conformal boost radiotherapy for 4 days, within 4 weeks after completion of conventional radiotherapy. Quality of life is assessed before radiotherapy, then at follow up visits. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 605 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven WHO grade III or IV glioma at primary diagnosis that enhance on preoperative imaging Glioblastoma Anaplastic astrocytoma Gliosarcoma Tumor volume no greater than 4.0 cm in maximum diameter on preoperative CT or MRI No prior histology of WHO grade I or II glioma Astrocytoma Oligodendroglioma No brainstem or infratentorial tumor No multifocal glioma Safe to treat tumor stereotactically No close proximity to critical structures, e.g., optic chiasm
  PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: WHO 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to tolerate full course of conventional radiotherapy No prior or concurrent medical condition that would preclude study therapy No prior malignancies within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No concurrent adjuvant chemotherapy Endocrine therapy: Concurrent steroids allowed Radiotherapy: See Disease Characteristics No prior radiotherapy to the head and neck area No prior radiotherapy to the brain No more than 6 weeks since other prior radiotherapy Surgery: See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Carmustine in Treating Patients With Recurrent Malignant Glioma

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.

Detailed description: OBJECTIVES:
  -  Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients undergoing surgery for recurrent malignant glioma.
  OUTLINE: This is a dose escalation study.
  All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity.
  Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from study.
  Patients are followed 3, 6, and 12 months after implantation.
  PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Pathologically confirmed recurrent malignant glioma for which surgery is indicated
  -  Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Karnofsky 60-100%
  Life expectancy:
  -  At least 8 weeks
  Hematopoietic:
  -  WBC at least 3,500/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal
  Renal:
  -  Creatinine less than 1.5 times normal
  -  BUN less than 2.5 times normal
  -  Protein no greater than 3 g/dL
  -  No gross hematuria
  Other:
  -  No hypersensitivity to nitrosoureas
  -  Not pregnant
  -  Fertile patients must use effective contraception
  -  No concurrent life threatening disease
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No concurrent immunotherapy during first 8 weeks of study
  Chemotherapy:
  -  At least 4 weeks since chemotherapy (6 weeks since nitrosoureas)
  -  No concurrent chemotherapy during first 8 weeks of study
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required
  -  No concurrent radiotherapy or brachytherapy during first 4 weeks of study
  Surgery:
  -  Prior cytoreductive surgery for supratentorial brain tumor required
  -  Biopsy alone not sufficient
  Other:
  -  No concurrent investigational therapy during first 8 weeks of study

Relevance to patient case: not relevant