araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

Summary: The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.

Detailed description: This trial began as a multi-center, randomized, Phase III, controlled trial for nilotinib vs (DTIC) dacarbazine to assess the efficacy and safety of nilotinib (400 mg bid) in patients with c-Kit mutated metastatic and/or inoperable melanoma. The study was open to patients with mucosal or acral melanoma.
  Due to substantial difficulties identifying and recruiting eligible patients, the trial design was altered from a randomized, two-arm, Phase III study to a single-arm, Simon two-stage Phase II study with protocol Amendment 2 (27-Jul-2011). While the original protocol required the recruitment of 120 patients, this amendment required the study to recruit only 41 patients (patients randomized to nilotinib prior to Amendment 2 were to be counted in this total, but those randomized to dacarbazine ( DTIC ) DTIC were not). Patients randomized to DTIC were allowed to cross-over to nilotinib, either immediately or at the time of progression.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed mucosal or acral 2. Presence of a c-Kit mutation of exon 9, 11 or 13, or mutations Y822D and mutations D820Y, Y823D of exon 17, as confirmed by the central laboratory 3. Stage III unresectable or stage IV disease 4. The presence of one or more measurable lesions as detected by radiological or photographic methods and assessed according to RECIST 1.0. Lesions must have a size of at least 10mm at longest diameter (using a slice thickness of 5 mm)or double the slice thickness to be considered a target lesion. Target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression 5. WHO performance status 0 - 2
  Exclusion Criteria:
  1. C-Kit mutation of exons 17(except mutations D820Y, Y822D or Y823D) or any other exon not allowed by the inclusion criteria
  2. Patients with c-Kit amplifications only and no mutation
  3. Patients with any history of brain metastases
  4. Patients who have had any prior treatment with TKIs
  5. Patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit
  6. Acute or chronic liver or renal disease considered unrelated to melanoma
  Other protocol-defined inclusion/exclusion criteria may have applied.

Relevance to patient case: possibly relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

Summary: The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).


Eligibility: Inclusion Criteria:
  -  Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
  -  Subjects chronically infected with HCV genotype 4 (Phase 2b only)
  -  HCV RNA viral load of ≥ 10*5* IU/mL at screening
  -  BMI of 18 - 35 kg/m² at screening
  Exclusion Criteria:
  -  Cirrhosis (Phase 2a only)
  -  Decompensated cirrhosis (Phase 2b)
  -  Co-infection with HBV or HIV
  -  Hepatocellular carcinoma
  -  Prior treatment with anti-HCV drugs

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

Summary: Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma (Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas (Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib alone and 56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008, abstr 10553).
  Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT mutations.


Eligibility: Inclusion Criteria:
  1. Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease
  2. Documented KIT aberration
  3. Adequate organ function as defined by the following criteria:
  -  Serum aspartate transaminase (AST); serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT); serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
  -  Total serum bilirubin ≤ 1.5 x ULN
  -  Absolute neutrophil count (ANC) ≥ 1500/µL
  -  Platelets ≥ 100,000/µL
  -  Hemoglobin ≥ 9.0 g/dL (may be transfused or erythropoietin treated)
  -  Serum calcium ≤ 12.0 mg/dL
  -  Serum creatinine ≤ 1.5 x ULN
  4. Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
  5. May have previous adjuvant therapy with interferon, vaccines or therapy with IL-2, chemotherapy
  6. At least one measurable lesion by RECIST criteria
  7. ECOG PS 0-2
  Exclusion Criteria:
  1. Major surgery or radiation therapy within 4 weeks of starting the study treatment.
  2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
  3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
  4. QTc > 470 msec on baseline EKG.
  5. Pregnancy or breastfeeding.

Relevance to patient case: possibly relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Comparison of Predictive Factors Related to Coronary Artery Disease Among Different Menopausal Status and Effect of a Life Style Management Program on Risk Factors Modification Among Middle-aged Women

Summary: In Taiwan, heart disease and cerebrovascular disease ranked the second and third of ten leading causes of death in female in 2007; half of these deaths is due to coronary artery disease (CAD). Postmenopausal status is an independent risk factor for CAD. Early assessment and proper management of risk factors may reduce the prevalence rate of CAD. In the past decade, despite increased attention to CAD in women, most studies focused on certain menopausal status instead of all phases of menopause or on risk factors limited to related metabolic syndrome. Because the prevalence of risk factors related to CAD is influenced by various physiological and lifestyle status in different menopausal statuses, the purpose of this study, at the first stage, is to explore respectively the risk factors of CAD among middle-aged women in three menopausal statuses. At the second stage, the influence of a lifestyle management program on risk factors modification among pre-menopausal women is examined in this study.


Eligibility: Inclusion Criteria:
  -  diagnosis of CAD by coroangiography
  -  LVEF >30%
  Exclusion Criteria:
  -  impairment of physical activity
  -  history of psychiatric disorder, vital arrhythmia

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Biomarkers in Young Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  Determine the frequency of ligand-independent phosphorylation of Stat3 in a small cohort of samples from pediatric patients with acute myeloid leukemia including, but not limited to, samples known to express mutated c-kit.
  -  Measure the level of Stat3 phosphorylation in these samples after stimulation of three key cytokine receptors expressed on hematopoietic cells IL-6R, G-CSFR, and c-kit.
  OUTLINE: Cryopreserved samples are analyzed for levels of various components of the Stat3 pathway via western blotting.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia
  -  One of the following karyotypes:
  -  t(8;21) and WT c-kit
  -  t(8;21) and mutant c-kit
  -  Normal karyotype
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Early Diagnosis of Malignant Transformation of Pigmentary Skin Lesions

Summary: Malignant Melanoma is a deadly skin cancer that can be cured if diagnosed early. To date atypical pigmented skin lesions are diagnosed by appearance alone and many moles and lesions are excised unnecessarily and on the other hand malignant lesions are missed and diagnosed too late. In this study a protein conjugated to a florescent dye is spread on a suspicious pigmented lesion, the hypothesis is that this protein binds to malignant cells only and thus with a special camera that picks up the dye we can find pigmented lesions with early malignant transformation.


Eligibility: Inclusion Criteria:
  -  pigmented lesion indicated for surgical excision
  -  over 18 years of age
  Exclusion Criteria:
  -  pregnancy

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

Summary: The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.

Detailed description: 1. Patients evaluation On all patients a complete clinical history and physical examination is performed, including routine hematology and biochemistry analyses. Hematology and biochemistry analyses are repeated at the end of each cycle. Toxicity is classified according to WHO criteria at each cycle for each patient. Response is assessed after two cycles of chemotherapy and every two cycles thereafter, using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
  2. Sample collection and SNP genotyping Venous blood (4 ml) is collected from each subject and placed into tubes containing EDTA. Genomic DNA is isolated with a DNA Blood isolation kit.Genotypes are performed by PCR-RFLP, PCR-DHPLC and PCR-direct sequencing, etc.
  3. Statistical Analysis x2 test is used to summarize the association of response and adverse events to chemotherapy with genetic polymorphisms.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed metastatic breast cancer
  -  Female
  -  An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  -  At least one measurable lesion
  -  Normal cardiac, hepatic, renal and bone marrow functions
  -  Life expectancy ≥3 months
  -  Discontinuity of previous chemotherapy for a minimum of 4 weeks
  Exclusion Criteria:
  -  Central nervous system metastases
  -  Serious or uncontrolled concurrent medical illness
  -  History of other malignancies

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

Summary: A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.


Eligibility: Inclusion Criteria:
  -  Patients meeting the Rome III Diagnostic Criteria
  -  Loose (mushy) or watery stools within the last 3 months
  -  Abdominal discomfort and/or pain during their non-menstrual period
  Exclusion Criteria:
  -  Patients with a history of surgical resection of the stomach, small intestine or large intestine
  -  Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
  -  Patients with a history or current diagnosis of colitis ischemic
  -  Patients with a current diagnosis of enteritis infectious
  -  Patients with a current diagnosis of hyperthyroidism or hypothyroidism
  -  Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
  -  Patients with a history or current diagnosis of malignant tumor
  -  Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: A Phase 3 Study to Compare Efficacy and Safety of Masitinib to Dacarbazine in the Treatment of Patients With Non-Resectable or Metastatic Stage 3 or Stage 4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of C-Kit

Summary: Masitinib is a novel TKI that potently inhibits wild type (WT) c-kit and its activated form, mutated in the juxtamembrane region (JM c-kit) PDGFRs, the intracellular kinase Lyn, and to a lesser extent fibroblast growth factor receptor 3 (FGFR3).
  Pre-clinical data suggest that masitinib is a strong candidate for the treatment of patients with advanced melanoma carrying a c-kit JM mutation.


Eligibility: Inclusion Criteria:
  -  Patient with histologically or cytologically confirmed non-resectable or metastatic stage 3 (non-resectable IIIB or IIIC, AJCC TNM staging system 7th edition) or stage 4 melanoma
  -  Patient with detectable c-kit JM mutation confirmed by DNA or RNA sequencing, which is expected to be mainly found after screening of mucosal or acral melanoma or melanoma on skin with chronic sun-induced damages (defined by a microscopically marked elastosis involving the skin surrounding their primary melanoma)
  -  Patient with measurable disease according to RECIST
  -  Patient with ECOG ≤ 2
  Exclusion Criteria:
  -  Patient with other malignancies from which the patient has been continuously disease-free for < 3 years, with the exception of melanoma, cervical carcinoma in situ, basal cell or squamous cell skin cancer, ductal or lobular carcinoma in situ of the breast
  -  Patient with active brain metastases are not eligible. Patients with treated brain metastases are eligible if :
  -  presence of 3 brain lesions or less
  -  lesion(s) diameter is ≤ 2 cm
  -  radiation therapy (gamma knife) was completed ≥ 4 weeks prior to baseline
  -  surgery was completed ≥4 weeks prior to baseline
  -  lesions assessed by follow-up scan (or MRI if MRI performed before brain therapy) ≥ 1 month after brain therapy are considered under control at baseline
  -  Patient refractory to dacarbazine defined as patient presenting a disease progression after 3 months of dacarbazine therapy.
  -  Prior treatment with a tyrosine kinase c-kit inhibitor

Relevance to patient case: possibly relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds

Summary: The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/ HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications (antiretroviral therapy).

Detailed description: We plan to perform liver biopsy by microlaparoscopy on previously untreated HIV/HCV coinfected persons, then give them a dose of peginterferon alfa 2b. HCV and HIV kinetics will be studied. Afterward, HIV will be treated using antiretroviral therapy and the procedure will be repeated.

Eligibility: Inclusion Criteria:
  -  Adult Human
  -  Able to provide written informed consent
  -  HIV antibody positive
  -  HIV viral load positive
  -  HIV treatment naive
  -  Hepatitis C antibody positive
  -  Hepatitis C viral load positive
  -  Hepatitis C treatment naive
  -  Approved to take HIV medications for minimum 9 months
  -  Willing to use contraception, Life expectancy greater than 2 years
  Exclusion Criteria:
  -  Significant opportunistic infections within 12 month
  -  Hepatitis B positive
  -  Evidence of liver cirrhosis
  -  Decompensated liver disease
  -  Chronic alcohol abuse
  -  Allergy to raltegravir, tenofovir, and/or emtricitabine
  -  Active or suspected malignancy
  -  Sarcoidosis
  -  Active TB
  -  Coronary artery disease
  -  Uncontrolled seizures
  -  Untreated thyroid disease
  -  Untreated diabetes
  -  Weight greater than 125 kg
  -  Severe depression or severe psychiatric disorder
  -  Ongoing alcohol or illicit drug use
  -  Pregnant, nursing, pr planning to become pregnant
  -  Allergy to interferon

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Liver Transplantation and Uveal Malignant Melanoma

Summary: Patients with uveal malignatnt melanoma with liver metastases have a dismal prognosis with a median survival of less than 12 months. There is noe established treatment showing increased overall survival. In this study we will determin if liver transplantation will result in long term survival in patients with liver only metastases from uveal malignant melanoma.


Eligibility: Inclusion Criteria:Uveal malignant melanoma, liver only metastases, ECOG 0-1 -
  Exclusion Criteria:Extra hepatic disease, previous other maligency, previous organ transplantation

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Detection of Choroidal Nevus Cells in Vitrectomy Fluid

Summary: The purpose of this study is to determine if the investigators can detect the presence of choroidal nevi cells in the vitreous fluid of humans, as this may improve the diagnosis and classification of choroidal nevi and melanomas in the future.

Detailed description: Approximately 7% of the population has a choroidal nevus, or "freckle," in the back of the eye. Like a nevus on the skin, there is potential for malignant change to a melanoma. Dermatologists have the ability to quickly and easily biopsy suspicious skin lesions while ophthalmologists currently have no way of determining the malignant potential of choroidal nevi other than a fine needle aspiration (which is invasive and has the potential complications of bleeding and retinal detachment). This study's sole aim is to see if choroidal nevi cells are present in the inside fluid of the eye. The investigators plan to analyze the fluid of the eye, which is routinely removed during retina surgery, to detect any nevus cells. If the investigators are able to detect these cells, then future studies may allow us to better classify choroidal nevi for potential malignant change.

Eligibility: Inclusion Criteria:
  -  Patients with a choroidal nevus who are undergoing routine vitrectomy surgery for another indication (such as epiretinal membrane or macular hole repair).
  Exclusion Criteria:
  -  Patients without a choroidal nevus
  -  Children under the age of 18
  -  Pregnant and nursing females

Relevance to patient case: not relevant
Patient case: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

Summary: The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

Detailed description: This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.

Eligibility: Inclusion Criteria:
  -  Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age (inclusive) with a diagnosis of osteoporosis
  -  The women are to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may also be enrolled if their T score is ≤ -3.0 and > -5.0
  -  Normal physical exam, vital signs, electrocardiogram (ECG) and medical history
  -  Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase
  Exclusion Criteria:
  -  History of more than 4 mild or moderate spine fractures or any severe fracture
  -  Abnormality of the spine or hip that would prohibit assessment of bone mineral density (BMD)
  -  Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such as Paget's disease) or a diagnosis of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
  -  History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
  -  Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid (PTHrP)
  -  Prior treatment with bisphosphonates, fluoride, or strontium within the past five years or treatment with androgens, anabolic steroids, corticosteroids or selective estrogen receptor modulators within the past 12 months (except hormone replacement therapy)
  -  Prior treatment with an investigational drug within the past 12 months
  -  History of nephrolithiasis or urolithiasis within the past five years, or history of osteosarcoma at any time

Relevance to patient case: not relevant