araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 47-year-old male with melanoma; genetic feature: APC 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: 47-year-old male with melanoma; genetic feature: APC 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: 47-year-old male with melanoma; genetic feature: APC 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: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

Summary: The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.


Eligibility: Inclusion Criteria:
  -  Diagnosed with acute hepatitis C virus (HCV).
  -  Normal and Elevated serum alanine transferase (ALT) levels
  -  Positive serum HCV-RNA.
  -  Aged between 18 and 65 years.
  -  Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion
  Exclusion Criteria:
  -  Liver disease unrelated to HCV infection
  -  Hemoglobin (Hgb) <12g/dL in women and <13g/dL in men; white blood cells (WBC) <3,000/uL; platelets (PLTs) <100,000/ul
  -  Women with ongoing pregnancy or who are breast feeding
  -  History of severe psychiatric disease, especially depression
  -  History of neurologic disease, especially epilepsy
  -  History or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
  -  Positive anti-Human Immunodeficiency Virus (HIV) antibodies
  -  Positive anti-nuclear antibodies (ANA) and/or Anti-Smooth Muscle Antibody (ASMA) (>1/80)
  -  Positive Hepatitis B surface antigen (HBsAg)
  -  History of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months
  -  History or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones

Summary: Most of HLA-A2 melanomas express Melan-A/MART-1 antigen and are recognized by tumor reactive Melan-A specific T lymphocytes. By using blood samples from HLA-A2 melanoma patients (stage III and IV), our goal is to produce a tumor reactive Melan-A specific T cell clones and to conduct a phase I-II clinical trial, based on the infusion of several millions to several billions of these lymphocytes to the patient, in order to induce passive immunity against this antigen. Production of the clones will be performed in the Unit for Cellular and Gene Therapy from Nantes University Hospital. Therapeutic response, safety treatment but also localization and survival of infused T cell clones will be assessed. This approach is expected to precise the ability of the clones to migrate within the tumor and to transfer specific immunity.


Eligibility: Inclusion Criteria:
  -  HLA-A2 melanoma patients with :
  -  either loco-regional or lymph node metastasis
  -  transit nodules not surgically resectable
  -  measurable cutaneous or visceral metastasis
  -  Patients' tumor express Melan-A/MART-1 antigen.
  -  No chemotherapy treatment (except for Deticene used before the first T cell clones infusion) or radiotherapy or immunotherapy in the last 4 weeks before infusion.
  -  No other melanoma treatment during the protocol.
  -  Life expectancy should be greater than 6 months.
  -  General state with Karnowsky greater than 80, ECOG = 0, 1 or 2.
  -  Patient should be negative for HIV and B and C hepatitis.
  -  Biological parameters at the beginning of the study: leucocytes ³ 2000 elements per mm3, hemoglobin ³ 10.5g/dl, platelets ³ 100 000 per mm3, phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal.
  -  Signed informed consent
  Exclusion Criteria:
  -  Cardio-vascular pathologies, evoluting and uncontrolled, (severe HTA), cardiac deficiency, severe angor, severe arrhythmia.
  -  Infectious pathologies evoluting and requiring antibiotherapy.
  -  Patients HIV+.
  -  Transplanted patients or patients suffering from severe auto-immune disease.
  -  Psychiatric troubles that do not allow the protocol follow-up.
  -  Pregnant or breast-feeding women.
  -  No contraception.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma

Summary: The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous)
  -  First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them)
  -  Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1
  -  Age ≥ 18 years
  -  ECOG ≤ 2
  -  Normal organ and marrow function as defined below:
  -  Leukocytes ≥2.5 x 109/L
  -  Absolute neutrophil count ≥1.5 x 109/L
  -  Platelets ≥100 x 109/L
  -  Hemoglobin ≥100 g/L (10g/dL)
  -  Total bilirubin ≤1.5 X institutional ULN
  -  AST(SGOT)/ALT(SGPT) ≤2.5 X institutional ULN
  -  Creatinine ≤1.5 X institutional ULN
  Exclusion Criteria:
  -  Patients with a life expectancy ≤ 16 weeks
  -  Patients with ocular melanoma
  -  Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1
  -  Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues
  -  Patients with a documented history of HIV, active hepatitis B or C infection
  -  Female patients who are pregnant or lactating
  -  Patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted)
  -  Patients with grade ≥2 peripheral neuropathy (CTCAE criteria)
  -  Patients in whom a proper central line cannot be established

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC 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: 47-year-old male with melanoma; genetic feature: APC 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: 47-year-old male with melanoma; genetic feature: APC 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: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis

Summary: Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.


Eligibility: Inclusion Criteria:
  -  Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis
  -  Spigelman score of duodenal adenoma equal to II or III
  Exclusion Criteria:
  -  Incapability of signing informed consent
  -  Active gastric or duodenal ulcer, gastrointestinal bleeding
  -  Cardiovascular disease or risk:
  -  Congestive cardiac failure: NYHA class II to IV
  -  Proven ischemic heart disease and/or cerebrovascular disease
  -  Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members <55 years)
  -  Renal dysfunction: creatinine clearance below 50mL/min
  -  Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10
  -  Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid
  -  Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study
  -  Use of lithium
  -  Symptomatic gallstones
  -  Inflammatory bowel disease
  -  (Possible) pregnancy or breast feeding

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC 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: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer

Summary: This 2 arm study will compare the efficacy and safety of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in participants who have not received prior chemotherapy for advanced or metastatic gastric cancer. Participants will be randomized to one of two treatment groups Bevacizumab + Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).


Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable, locally advanced or metastatic disease, not amenable to curative therapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
  -  Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
  Exclusion Criteria:
  -  Previous chemotherapy for locally advanced or metastatic gastric cancer
  -  Previous platinum or anti-angiogenic therapy
  -  Radiotherapy within 28 days of randomization
  -  Evidence of Central Nervous System (CNS) metastasis at baseline

Relevance to patient case: not relevant