araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

Summary: The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the health of the body's immune system)

Detailed description: Intervention model: Dosing is sequential

Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
  Key Inclusion Criteria:
  Participants with a confirmed diagnosis, according to criteria of the International Myeloma Working Group, of smoldering multiple myeloma, considered high risk according to the following:
  -  Serum monoclonal (M) protein ≥3 gm/dL and bone marrow plasma cells (BMPC) ≥10% or
  -  Serum M protein 1-3 g/dL and BMPC ≥10% and abnormal free light chain ratio of <0.125 or >8.0
  -  Urine M protein >200 mg/24 hours, ≥10% BMPC, and serum free light chain ratio ≤0.125 or ≥8.0
  Key Exclusion Criteria:
  -  Active multiple myeloma
  -  Monoclonal gammopathy of undetermined significance
  -  Active plasma cell leukemia
  -  Positive for hepatitis B or C virus or HIV infection

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

Summary: The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
  Inclusion Criteria:
  -  Unresectable Stage III or Stage IV melanoma
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  Exclusion Criteria:
  -  Brain metastases with symptoms or requiring treatment
  -  History of autoimmune disease

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Tenofovir in Chronic Hepatitis B With Mild ALT Elevation

Summary: This study aims to clarify whether patients with chronic hepatitis B with high viral load will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.

Detailed description: Chronic hepatitis B (CHB) is a serious disease in Taiwan, leading to substantial morbidity and mortality including hepatic failure, liver cirrhosis, and hepatocellular carcinoma (HCC). Recently a large body of evidence supports that high level of serum HBV DNA is an independent risk factor for late complications in CHB patients. Nucleos(t)ide analogues (NUC) are effective antiviral therapy that can potently inhibit replication of hepatitis B virus (HBV), and has been widely used in management of patients with CHB. Current practice guidelines recommend using serum alanine aminotransferase (ALT) > 2 times of the upper limit of normal (ULN) as the prerequisite to initiate antiviral therapy in compensated CHB patients without liver cirrhosis. However, serum ALT level does not exactly correlate with serum HBV DNA or liver tissue injury. Whether antiviral therapy improves outcomes of patients with slightly elevated ALT (i.e. 1-2 folds of ULN) remains unknown.

Eligibility: Inclusion Criteria:
  -  age between 25 to 70 years,
  -  serum HBsAg positivity for more than 6 months,
  -  positive or negative serum HBeAg,
  -  serum HBV DNA more than 2,000 IU/mL,
  -  highest serum ALT > 1 fold of ULN, but < 2 X ULN on at least two occasions (≧ 3 months apart) in the preceding one year,
  Exclusion Criteria:
  -  co-infection with HIV, HCV, or HDV,
  -  previous exposure to HBV antiviral therapy for more than 12 weeks,
  -  presence of cirrhosis on histopathology,
  -  hepatic decompensation defined as serum bilirubin > 2mg/dl and prolonged prothrombin time > 3 seconds,
  -  concurrent malignant diseases including hepatocellular carcinoma,
  -  severe co-morbidity with life expectancy < 1year,
  -  pregnant or lactating women,
  -  organ transplantation except cornea or hair transplant,
  -  suspected or confirmed chronic liver diseases from etiologies other than HBV (e.g. alcoholic hepatitis, Wilson disease, Hemochromatosis…etc),
  -  serum creatinine >1.5mg/dL

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Development of a Screening Tool to Detect and Stage Cachectic Cancer Patients

Summary: The aim of the study is to develop a screenings tool that will enable hospital nurses to detect and stage cancer cachectic patients. The early detection and staging of cancer cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made patient care.

Detailed description: In this cross-sectional study, the participants will complete 4 times a set of questionnaires and measurements. The data that will be collected is:
  age; sex; height; weight; type of tumour; classification of malignant tumours (TNM); progression of tumour and used therapy; blood sample to analyse albumin, creatine, hemoglobin, LDH and CRP; use of parental nutrition; dietary assessment; use of nutritional supplements; Quality of Life by using the EORTC-QlQ; Subjective Global Assessment; presence of Percutaneous endoscopic gastrostomy; use of enteral or parenteral nutrition; body composition based on a Bio Impedance Assessment; hand grip strength and mid upper arm circumference. Based on all these data points a easy to use tool/score for a hospital setting will be created. During the first assessment the measurements will be done in the morning and the evening to test the reproducibility.

Eligibility: Inclusion Criteria:
  -  New Diagnosed Patients With Primary Head and Neck Cancer Neoplasms
  -  New Diagnosed Patients With Metastatic Pancreatic Neoplasms
  -  New Diagnosed Patients With Metastatic Colonic Neoplasms
  Exclusion Criteria:
  -  Patients With Other Primary Neoplasms
  -  Patients Already in Therapy
  -  Patients With Non-metastatic Colonic or Pancreatic Neoplasms

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients

Summary: The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed Stage IIb, IIc, III melanoma
  -  Surgical resection within 90 days of first dosing
  -  Persons with positive sentinel nodes must have a complete lymphadenectomy
  -  ECOG performance status 0 or 1
  Exclusion Criteria:
  -  Any prior melanoma treatment other than surgery or regional irradiation
  -  Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
  -  Use of biologic response modifiers within 60 days of first dosing
  -  Subjects with history of other malignancy within past 5 years (with exceptions)

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma

Summary: Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. The detection of CTC by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown encouraging results. The investigators propose a prospective study of the CellSearch system in patients with melanoma.
  Primary objective: To determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma.
  Secondary objectives:
  -  determine the percentage of patients with metastatic melanoma with melanoma cells circulating
  -  seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma
  -  seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma


Eligibility: Inclusion Criteria:
  -  Patients > or = 18 years
  -  Patients with advanced melanoma stage IIIC (unresectable) or stage IV
  -  Patient not treated or not responding to chemotherapy with chemotherapy session last> 1 month
  -  Patients who signed informed consent
  -  Patients presenting no socio-economic, psychological, familial or geographical allow proper understanding of the information leaflet of the protocol or the regular monitoring in the department of dermatology
  -  Patients with a life expectancy greater than 3 months
  -  Patients with melanoma measurable by RECIST version 1.1
  -  Patients with venous good for venipuncture
  Exclusion Criteria:
  -  Patients with contraindication for treatment with chemotherapy or V600E BRAF inhibitor or ipilimumab or have conditions concomitant heavy may interfere with the treatment of metastatic melanoma
  -  Pregnant women or nursing
  -  People vulnerable detainees, adults under guardianship or curatorship, minors.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

Summary: This is a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy to dabrafenib administered with a trametinib placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive will be screened for eligibility. Subjects who have had prior systemic anti-cancer treatment in the advanced or metastatic setting will not be eligible although prior systemic treatment in the adjuvant setting will be allowed. Approximately 340 subjects will be randomized 1:1 (combination therapy: dabrafenib monotherapy). Subjects will be stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus less than or equal to the ULN) and BRAF mutation (V600E versus V600K). The primary endpoint is investigator-assessed, progression-free survival for subjects receiving the combination therapy compared with those receiving dabrafenib monotherapy. Subjects will be followed for overall survival; crossover will not be permitted.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive using the bioMerieux (bMx) investigational use only (IUO) THxID BRAF Assay (IDE: G120011). The assay will be conducted by a central reference laboratory. Subjects with ocular or mucosal melanoma are not eligible.
  -  The subject must have a radiologically measurable tumor
  -  The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
  -  Able to swallow and retain oral medication
  -  Sexually active subjects must use acceptable methods of contraception during the course of the study
  -  Adequate organ system function and blood counts
  Exclusion Criteria:
  -  Prior treatment with a BRAF or a MEK inhibitor
  -  Prior systemic anti-cancer treatment for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma. Prior systemic treatment in the adjuvant setting is allowed. (Note: Ipilimumab treatment must end at least 8 weeks prior to randomization.)
  -  The subject has received major surgery or certain tyes of cancer therapy with 21 days of starting treatment
  -  Current use of prohibited medication listed in the protocol
  -  Left ventricular ejection fraction less than the lower limit of normal
  -  Uncontrolled blood pressurl
  -  History or current evidence of retinal vein occlusion or central serous retinopathy
  -  Brain metastases unless previously treated with surgery or stereotactic radiosurgery and the disease has been stable for at least 12 weeks
  -  The subject is pregnant or nursing

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With INCB024360 or Placebo in Subjects With Unresectable or Metastatic Melanoma

Summary: The study design includes an open-label, dose escalation phase followed by a blinded, randomized phase, which combines INCB024360 (an oral IDO1 inhibitor) with an approved therapy and compares to approved therapy plus placebo in metastatic melanoma patients.


Eligibility: Inclusion Criteria:
  -  Male or female subjects, aged 18 years or older with unresectable or metastatic melanoma.
  -  A life expectancy of >12 weeks.
  -  Laboratory ranges and medical criteria met, as defined within the protocol.
  -  Subject may have received more than 1 prior regimen of systematic treatment for unresectable or metastatic melanoma.
  -  For Phase 2 period of the study only, Subjects must have archival tumor tissue available and collected with the prior 6 months or accessible disease for pre-treatment, study biopsy.
  Exclusion Criteria:
  -  Pregnant or nursing women.
  -  Current investigational trial participation with another investigational product or subjects who have received any anticancer medications within 21 days prior to screening (6 weeks for mitomycin-C or nitrosoureas.)
  -  Subjects receiving monoamine oxidase inhibitors (MAOI)s; subjects who have ever had Serotonin Syndrome after receiving one or more serotonergic drugs.
  -  Subjects who have received prior immune checkpoint inhibitors (eg anti-CTLA-4, anti-PD-1, anti- PD-L1 and others) who have had Grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other Grade 4 immune adverse events (AEs) or ocular toxicity
  -  Subjects with protocol-specified active autoimmune process except vitiligo or thyroiditis.
  -  Subjects with concurrent conditions that would jeopardize the safety of the safety of the subject or compliance with the protocol.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Summary: Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.


Eligibility: Inclusion Criteria:
  -  patients more than 18 years old,
  -  consulting their GP,
  -  assessed at risk for melanoma according to the SAMScore
  -  signed the consent.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Leptin Levels in Papillary Thyroid Cancer

Summary: The purpose of this study is to evaluate Leptin levels in females, in the setting of papillary thyroid cancer, benign thyroid nodules, and in normal females without thyroid disease.

Detailed description: There will be three groups in this study, but 2 of the groups are part of another study so will only recruit normal controls.

Eligibility: Inclusion Criteria:
  -  Female
  -  Age>/- 19
  -  Not currently pregnant or lactating
  -  Normal thyroid gland by history
  Exclusion Criteria:
  -  Male Gender
  -  Pregnancy
  -  Lactation
  -  Age below 19
  -  Abnormal thyroid gland by history
  -  Abnormal thyroid gland by structure using ultrasound
  -  Abnormal thyroid gland by function using TSH, Free T4

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Pilot Study Investigating the Metabolic Activity and Transcriptional Profiling in Vivo in Tumor Biopsies in Melanoma Patients During Treatment With Pazopanib Alone and in Combination With Paclitaxel

Summary: This is an open, monocentric, pilot study to determine the metabolic activity (glucose-uptake) in vivo during monotherapy with pazopanib in comparison to combination therapy with pazopanib plus paclitaxel and to investigate the transcriptional profile of cutaneous melanoma metastasis before and during the therapy (pazopanib vs. pazopanib plus paclitaxel) in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy.
  Primary Objective:
  Evaluation of metabolic activity in vivo
  Secondary Objective:
  Determination of changes in gene expression profiling Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS). Changes in S100 and LDH during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)
  -  Trial with medicinal product


Eligibility: Inclusion criteria:
  -  Age ≥ 18 years
  -  Diagnosis of histologically or cytologically confirmed melanoma stage III or IV.
  -  Fresh tumor tissue must be provided for all subjects for biomarker analysis before (within 14 days prior to treatment start) and during (on day 10 of the pazopanib monotherapy and the last day of the treatment with pazopanib, day 70) treatment with investigational product (asservation in RNAlater, for kryo asservation, and for cell cultures)
  -  Assessable metastases (skin or superficial lymph nodes with a minimal diameter 1 cm)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  Adequate organ system function
  Exclusion criteria:
  -  Prior malignancy.
  -  Central nervous system (CNS) metastases
  -  Corrected QT interval (QTc) > 480 msecs using Bazett's formula.
  -  History of any one or more of the following cardiovascular conditions within the past 6 months:
  -  Cardiac angioplasty or stenting;
  -  Myocardial infarction;
  -  Unstable angina;
  -  Coronary artery bypass graft surgery;
  -  Symptomatic peripheral vascular disease;
  -  Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
  -  Poorly controlled hypertension
  -  History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  -  Presence of uncontrolled infection
  -  Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
  -  Evidence of active bleeding or bleeding diathesis
  -  Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
  -  Prior exposure to the study drug pazopanib

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma

Summary: The purpose of this study is to determine the survival rate after 1 year of treatment with ipilimumab plus dacarbazine in patients with previously untreated Stage III (unresectable) or Stage IV melanoma.


Eligibility: Key inclusion criteria:
  -  Japanese patients with histologic diagnosis of malignant melanoma
  -  Previously untreated Stage III with N3 (unresectable) or Stage IV melanoma
  -  Prior adjuvant melanoma therapy permitted
  -  Eastern Cooperative Oncology Group performance status of 0 or 1
  -  Life expectancy of at least 16 weeks in this study
  -  Adequate bone marrow and renal and hepatic function, specifically:
  -  white blood cell count ≥2500/uL, absolute neutrophil count ≥1000/uL, platelet count ≥75,000/uL, hemoglobin level ≥9.0 g/dL, creatinine level ≤2.5*upper limit of normal (ULN), aspartate transaminase/alanine transaminase level <2.5*ULN for patients without liver metastasis and <5*ULN for patients with liver metastasis, total bilirubin level <1.5*ULN (for those with Gilbert's Syndrome, lower than 3.0 mg/dL)
  Key exclusion criteria:
  -  Evidence of brain metastases on brain imaging
  -  Active brain metastases with symptoms or requiring corticosteroid treatment; patients with any other malignancy from which they have been disease-free for fewer than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
  -  Primary ocular or mucosal melanoma
  -  History of or current active autoimmune disease
  -  History or concurrent disease of gastrointestinal perforations
  -  HIV infection; active Hepatitis B or C or human T-lymphotropic virus type1 infection, based on testing performed during the screening period of this study
  -  Prior or concomitant therapy with any anticancer agent for melanoma, or other investigational anticancer therapies
  -  Prior adjuvant therapy <4 weeks prior to the start of study drug administration
  -  Concomitant therapy with immunosuppressive agents, surgery, or radiotherapy
  -  Prior treatment with CTLA-4 inhibitors/agonists or other experimental immunotherapy drugs
  -  Treatment with other investigational products within 4 weeks prior to initial treatment of study drug

Relevance to patient case: not relevant