araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions

Summary: The incidence of malignant melanoma has increased dramatically in recent decades. In 1930, the lifetime risk of an individual in the United States developing melanoma was 1 in 1,500. This has been exponentially increasing over the years with the risk estimated to be 1 in 75 in 2000 . According to the American Cancer Society, approximately 59,580 new cases of melanoma will be diagnosed in the United States in 2005 and about 7,770 people are expected to die of the disease.

Detailed description: The researcher ucan use special imaging devices to obtain information about a typical mole and melanoma and use this information to determine the different between malignant and benign melanized lesions. The imaging devices are, Modified Two Layer Diffuse Optical Spectroscopy,multi-spectral imaging, and Spatially Modulated Quantitative Spectroscopy can use to measure atypical moles and melanoma and correlate the results of the biopsy tissue histology.
  The imaging devices can quantify melanin, oxy and deoxy hemoglobin concentration, water, lipid and reduced scattering coefficients and can compare results to histopathologic. Atypical moles and melanoma have a different optical profile based on physiological parameters compared to benign nevus.

Eligibility: Inclusion Criteria:
  -  18 years or older.
  -  Have atypical mole/s and melanoma
  Exclusion Criteria:
  -  Age less than 18 years old.
  -  have NO atypical mole/s and melanoma

Relevance to patient case: not relevant
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: Exercise for Physical Health in Men With Prostate Cancer

Summary: The purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength and impact exercise training to flexibility/relaxation training on body composition (bone, muscle and fat mass), physical function (strength, gait, power, balance and self-report physical function and symptoms) in men currently treated with hormone therapy for prostate cancer.

Detailed description: Prostate cancer survivors with advanced disease are commonly treated with androgen deprivation therapy (ADT) to reduce testosterone. Serious side effects of ADT are rapid bone and muscle loss that can lead to osteoporosis and declines in neuromuscular function (strength, power, gait and balance) which increases the risk of fracture and falls (a risk factor for fracture) and impairs physical function. Men on ADT are 1.4 times more likely to fracture compared with their cancer-free peers and those who fracture have a poorer prognosis than those who do not. Self-report physical function is also lower among men on ADT. Exercise can prevent bone loss, neuromuscular declines and falls in several populations. However, the ability of exercise to prevent bone loss from ADT has not been tested, while data on exercise and neuromuscular function (strength only) in this population are limited to one published trial. The long-term goal of our research is to improve musculoskeletal health and function in cancer survivors. Critical first steps to meet this goal are to determine whether our previously tested program of impact and resistance exercise, shown to improve bone health and neuromuscular function in women, can prevent bone loss and neuromuscular declines in prostate cancer survivors on ADT. Based on our previous research, we have developed the Prevent Osteoporosis With Impact + Resistance (POWIR) program to be adapted to clinical populations at risk for bone loss and declines in neuromuscular function. Potentially, POWIR could mitigate bone and muscle losses from ADT, and thereby lower fracture risk and improve quality of life.

Eligibility: Inclusion Criteria:
  -  histologically confirmed prostate cancer
  -  presently receiving or planning to begin androgen deprivation therapy for prostate cancer
  Exclusion Criteria:
  -  Presence of bone metastases in the proximal femur and lumbar spine
  -  Clinically defined osteoporosis
  -  Current or previous use of medications known to affect bone metabolism
  -  Current regular participation (>2x/wk for at least 30 min/session) in a planned session of moderate-vigorous impact or resistance training
  -  A medical condition, disorder, or medication that contraindicates participation in moderate intensity impact or resistance exercise

Relevance to patient case: not relevant
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF

Summary: Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization). It is hoped with this novel approach that:
  -  tumor cells will die due to a loss of their blood supply,
  -  local inflammatory reactions induced by GM-CSF will kill remaining tumor cells, and
  -  a systemic immune response against tumor cells may develop.

Detailed description: Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization).

Eligibility: Inclusion Criteria:
  -  Metastatic uveal melanoma in the liver with histological confirmation
  -  Ability/willingness to give informed consent
  -  ECOG performance status of 0 or 1
  -  Adequate renal, liver and bone marrow function
  Exclusion Criteria:
  -  Solitary liver metastasis that is amenable to surgical removal
  -  Presence of symptomatic liver failure including ascites and hepatic encephalopathy
  -  Presence of extra-hepatic metastases
  -  Untreated brain metastases
  -  Uncontrolled hypertension or congestive heart failure or acute myocardial infarction within 6 months of entry
  -  Presence of any other medical complication that imply survival of less than six months
  -  Uncontrolled sever bleeding tendency or active GI bleeding
  -  Significant allergic reaction to contrast dye or GM-CSF
  -  Immunosuppressive treatments such as systemic steroids, radiation to pelvis or systemic chemotherapy within 4 weeks
  -  Previous embolization of the hepatic artery or intrahepatic arterial chemotherapy of liver metastasis
  -  Active hepatitis with serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) greater than 5 x normal
  -  HIV infection positive by ELISA
  -  Pregnancy or breast feeding women
  -  Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy
  -  Significant arteriovenous shunt identified on angiography of the hepatic artery
  -  Occlusion of main portal vein or inadequate collateral flow around an occluded portal vein

Relevance to patient case: not relevant
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: Ghrelin - A Possible Opportunity to Improve Appetite

Summary: The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.

Detailed description: Randomized study with follow up evaluations each month until preterminal state. Cancer patients will be randomised to either high dose or low dose of active treatment given as daily injection.

Eligibility: Inclusion Criteria:
  -  Weight loss
  Exclusion Criteria:
  -  Diabetes

Relevance to patient case: not relevant
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: Study of Genes and the Environment in Patients With Prostate Cancer Residing in the East Anglia, Trent, or West Midlands Regions of the United Kingdom

Summary: RATIONALE: Studying 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 study is looking at genetic susceptibility and the interactions between genes and the environment in patients with prostate cancer.

Detailed description: OBJECTIVES:
  -  To obtain epidemiological information and biological material on a population-based series of prostate cancer cases.
  -  To identify novel cancer susceptibility genes by comparison of genotype frequencies in cases with the corresponding frequencies in large control series.
  -  To estimate the age and sex-specific risks associated with variants in predisposition genes.
  -  To evaluate interactions between polymorphisms in predisposition genes and potential lifestyle risk factors.
  OUTLINE: This is a multicenter study.
  Patients complete a detailed epidemiological questionnaire, including information on education, occupation, smoking habits, alcohol consumption, height, weight, family history of cancer, and past medical history.
  Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.
  In addition to the prostate cancer patients recruited for this study, patients with breast, ovarian, endometrial, colorectal, bladder, kidney, pancreatic, brain and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of prostate cancer within the past 5 years
  -  Identified through the cancer registry serving any of the following geographic regions of the United Kingdom:
  -  East Anglia
  -  Trent
  -  West Midlands
  PATIENT CHARACTERISTICS:
  -  Identified by the patient's general practitioner as fit to contact for this study
  -  No serious mental illness or retardation
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Summary: The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.


Eligibility: Inclusion Criteria:
  -  Patients with newly diagnosed choroidal melanoma undergoing proton therapy
  -  Tumors >15 mm in largest diameter and/or >5 mm in height
  -  Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye
  Exclusion Criteria:
  -  History of prior treatment for choroidal melanoma
  -  Pregnancy or lactation
  -  Presence of diabetic retinopathy
  -  History of retinal vascular occlusion or other retinal vascular disease
  -  Active ocular inflammation or history of uveitis in either eye
  -  History of uncontrolled glaucoma (defined as intraocular pressure >30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
  -  Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days.
  -  Concurrent use of systemic anti-VEGF therapy

Relevance to patient case: not relevant
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: Feasibility and Functionality of fPAM Imaging in Melanoma

Summary: Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional (lymph node) recurrence. These recurrences may be difficult to detect in their earliest stages. We are attempting to use novel form of skin imaging that uses ultrasound combined with laser to identify these recurrences early, when they may be most amenable to treatment. This imaging will detect melanoma pigment below the surface of the skin and in the draining lymph nodes, as well as new blood vessel formation that occurs with these loco-regional metastases.

Detailed description: recruiting healthy individuals with pigmented lesions and individuals with melanoma and pigmented lesions

Eligibility: Inclusion Criteria:
  -  Adult patients (> 18 yrs of age) with recently diagnosed or a history of, Stage I - III melanoma who are able to give informed consent.
  Exclusion Criteria:
  -  Patients with melanomas < 1mm.
  -  Pregnant females.
  -  Children and young adults < 18 yrs of age and patients who are unable to give informed consent.

Relevance to patient case: not relevant
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors

Summary: This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


Eligibility: Inclusion Criteria:
  -  adult patients, >=18 years of age;
  -  advanced and/or metastatic cancer not amenable to standard therapy;
  -  any solid tumor type (Part 1); malignant melanoma or other responsive tumor type (Part 2);
  -  measurable and/or evaluable disease (Part 1); >=1 measurable lesion (Part 2);
  -  ECOG performance status 0-2.
  Exclusion Criteria:
  -  prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
  -  prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
  -  active CNS lesions;
  -  acute or chronic infection.

Relevance to patient case: not relevant
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: Haploidentical NK Cell Infusion in Malignant Melanoma

Summary: We hypothesized that haploidentical NK cells kill tumor cells more efficiently than autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study to investigate the role of haploidentical NK cell therapy in patients with refractory or relapsed malignant melanoma.

Detailed description: Human NK cells recognize and kill transformed cells in a MHC-unrestricted fashion, suggesting the role of cancer immunotherapy. However, autologous NK cells showed the lack of significant clinical effects, because they are inhibited by self MHC class I molecules, based on the missing-self hypothesis. Contrarily, haploidentical NK cells with KIR-ligand incompatibility can mediate graft-versus-leukemia effect and protect patients with acute myelogenous leukemia (AML) from graft-versus-host disease. In addition, adoptive transfer of haploidentical NK cells following high-intensity conditioning induced complete remission (26%) in poor-prognosis AML patients. Thus, this study was designed to investigate the role of adoptive NK cell therapy in patients with refractory or relapsed malignant melanoma using CD3+ depleting CliniMACS® system.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed metastatic or relapsed malignant melanoma
  -  Patients who received prior chemotherapy or immunotherapy
  -  Patients who have at least one haploidentical donor willing to donate
  -  ECOG performance status 0 or 1
  -  18 - 75 years
  -  At least one measurable disease according to the RECIST criteria
  -  Patients with 45% or more left ventricular ejection fraction
  -  Patients with 50% or more predicted DLCO
  -  Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; and hemoglobin ≥ 9 g/dL
  -  Adequate liver function: total bilirubin ≤ 1.0 x upper limit of the normal range (ULN); AST/ALT ≤ 2.5 x ULN; and alkaline phosphatase ≤ 2.5 x ULN
  -  Adequate renal function: serum creatinine ≤ 1.0 x ULN or creatinine clearance ≥ 60 mL/min/1.73m2
  -  At least 3 months of expected survival
  -  Patients who signed informed consent
  Exclusion Criteria:
  -  Patients who received other chemotherapeutic agents within 30 days prior to study enrollment
  -  Patients who received adoptive cell therapy including hematopoietic stem cell transplantation
  -  Patients infected with HIV, HBV, or HCV
  -  Hypersensitivity to cyclophosphamide or interleukin-2
  -  Patients who received organ transplantation
  -  Patients who had arrhythmia or ischemic heart disease
  -  Pregnant or lactating women
  -  Patients with uncontrolled infection who did not respond to appropriate antimicrobial agents

Relevance to patient case: not relevant
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

Clinical trial: Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma

Summary: The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other investigators have used CVT in melanoma patients and found that tumors got significantly smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of how many patients will respond to CVT. Also they want to test which genes in the tumor are turned on and which are turned off. We hope this will teach us to know in the future which tumors will respond to CVT.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Histologic proof of melanoma reviewed and confirmed at MSKCC
  -  Patients must have stage IV melanoma or recurrent stage IIIb or IIIc melanoma. Patients who are potentially respectable will be eligible.
  -  Measurable disease (RECIST criteria). Patients must have a tumor amenable to biopsy for oligonucleotide microarray analysis and for immunohistochemistry. A pre-treatment biopsy is required; a fine needle aspirate is not adequate.
  -  No prior cytotoxic chemotherapy for melanoma. Prior immunotherapy or anti-angiogenic therapy is allowed.
  -  No other concurrent chemotherapy, immunotherapy, or radiotherapy
  -  ECOG performance status ≤ 1
  -  Adequate organ function defined as follows: ANC >1500/mm3, Platelets >130,000/mm3, calculated creatinine clearance ≥60 ml/minute (Cockcroft & Gault).
  -  Adequate cardiac function to tolerate the hydration needed for cisplatin administration.
  Exclusion Criteria:
  -  History of CNS metastases unless brain metastases have been resected or successfully treated with stereotactic radiosurgery and the patient has been free from CNS recurrence for 3 months.
  -  Uveal melanoma primary
  -  Patients who have had prior anti-CTLA4 monoclonal antibody treatment must have been off treatment for at least 4 months and have signs of progression of disease.
  -  Frequent vomiting or medical conditions that could interfere with oral medication intake
  -  Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
  -  History of HIV infection even if on HAART
  -  Immunosuppressive drugs
  -  High dose vitamins and herbs
  -  Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.

Relevance to patient case: not relevant
Patient case: 72-year-old male with melanoma; genetic feature: TP53 loss of function

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