araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Evaluating the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

Summary: The purpose of this study is to determine the safety and efficacy of oral E7080 in medullary and iodine-131 refractory, unresectable differentiated thyroid cancers.

Detailed description: This will be an open-label study at approximately 50 study centers in the US, Europe and other countries. The study will consist of a screening period (Pre-Treatment Phase), 28-day treatment cycles (Treatment Phase), and a study termination/final visit and survival follow-up. Patients showing clinical benefit will continue to receive the study drug (Extension Phase) and will be followed up with the appropriate assessments.

Eligibility: Inclusion criteria:
  1. Patients must have histologically or cytologically confirmed diagnosis of Medullary Thyroid Cancer (MTC) or Differentiated Thyroid Cancer (DTC).
  2. Measurable disease meeting the following criterion:
  1. At least one lesion (≥ 1.5 cm in longest diameter for non-lymph nodes and ≥2.0 cm in longest diameter for lymph nodes) which is serially and accurately measurable according to Modified Response Evaluation Criteria in Solid Tumors (RECIST) using either computed tomography (CT) or magnetic resonance imaging (MRI)
  2. Lesions that have had electron beam radiotherapy must show evidence of progressive disease based on Modified Response Evaluation Criteria in Solid Tumors (RECIST) to be deemed a target lesion
  3. Patients must show evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) using site assessment of computed tomography/magnetic resonance imaging (CT/MRI) scans within 12 months (+1 month to allow for variances in patient scanning intervals) prior to study entry.
  4. Patients with Differentiated Thyroid Cancer (DTC) must be 131-I refractory/resistant: never demonstrated 131-I uptake, progression despite 131-I uptake, or cumulative dose of 131-I of > 600 mCi (last dose given at least 6 months prior to study entry).
  5. Well controlled blood pressure prior to study entry.
  6. Signed informed consent.
  Exclusion criteria:
  1. Anaplastic thyroid carcinoma, thyroid lymphoma, mesenchymal tumors of the thyroid, metastases to the thyroid.
  2. Brain or leptomeningeal metastases.
  3. Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association [NYHA] Class II, unstable angina or myocardial infarction within 6 months of study start, or serious cardiac arrhythmia).
  4. Marked baseline prolongation of QT/QTc interval.
  5. Proteinuria > 1+ or > 30 mg in dipstick testing.
  6. Active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to study entry.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Multicentric Cohort of Melanoma Patients in Ile de France Area

Summary: This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the largest consortium of University hospitals over Europe. 7 investigation sites (7 dermatological services of AP-HP) in Ile de France region are involved. 1300 patients will be enrolled and be followed during 10 years.

Detailed description: Melan-Cohort should constitute the first multicentric cohort with various objectives: prognostic, therapeutic, cognitive and medico-economical studies on melanoma. Patients will be recruited in all of the dermatology departments of APHP (dermatology departments from AMBROISE PARE, Saint-Louis, BICHAT-Claude Bernard,Henri-Mondor, Cochin-Tarnier, and Tenon hospitals). For all included patients, a standard file is filled comprising all anatomy-clinical useful data and epidemiologic ones, including sun exposures. Blood is harvested to collect DNA, RNA, serum, plasma at inclusion and at regular intervals and in case of progressive disease. Procedures for sentinel lymph node biopsies have been homogenized. An informed consent is obtained for each patient included in the cohort. A steering committee meets on a regular basis, and genetics or pathology subgroups have been constituted. An electronic CRF is available using the Intranet of APHP hospitals. Specimens are stored using high quality standards.

Eligibility: Inclusion criteria :
  -  age ≥ 18 years
  -  an informed consent is obtained
  -  patients with anatomy-pathologically proved melanoma
  -  the tissue sample of melanoma is available
  -  the primary melanoma is treated according to the international standard
  -  absence of a progressive non neoplastic pathology involving life-threatening
  -  patient living in Ile de France region.
  -  time limit to entry in the cohort must be:
  -  within 3 months after Surgical resumption of primary melanoma;
  -  within 3 months after curative surgical treatment;
  -  with one month after diagnosis of a transit metastasis or a distant metastasis.
  Exclusion criteria :
  -  refusal of the patient
  -  pathology sample isn't available
  -  primary melanoma not being treated according to the international standard
  -  patient living too far to follow regular visits
  -  patient diagnosed with a progressive non neoplastic pathology involving life-threatening
  -  too late to entry and lack of useful stored specimens to research.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma

Summary: Though it is generally accepted that exposure to sunlight is a major causative factor for skin cancer, the risk for developing melanoma is not directly linked to sun exposure such as in non-melanoma skin cancer. Therefore, a dual pathway has been proposed, distinguishing melanoma that develops on skin that is chronically exposed to sunlight from those that occur on skin that is normally protected. The risk for each type of melanoma is believed to be determined in part by genetic factors. To define these markers reproducibly, the investigators plan to establish a large cohort with comprehensive information regarding sun sensitivity (skin type), history of experienced sun exposure, skin pigmentation phenotypes, total number of nevi, and other types of skin tumors in a central European population. The investigators will obtain blood from all participants for DNA as well as serum analyses. Based on the finding that genetic variants of the melanocortin-1 receptor (MC1R) gene, associated with red hair and fair skin, have been shown to be associated with increased risk for melanoma, particularly those harboring BRAF mutations, the investigators will now focus on the study of recently discovered genetic variants associated with pigmentation. Furthermore, the investigators will study the relation of these variants with oncogenic mutations of melanoma in BRAF, RAS and c-Kit. The study of other genetic variants will follow, once a sufficiently large cohort has been established to reveal an independent genetic risk factor in a multivariate analysis including potential covariates as mentioned above. The identification of genetic risk factors for melanoma will not only help identify individuals with increased risk but also improve our understanding of the molecular background of the development of melanoma.


Eligibility: Inclusion Criteria:
  -  patients with or without melanoma
  Exclusion Criteria:
  -  HIV and Hepatitis C positive individuals.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

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
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Study of Tumor Tissue From Patients With Melanoma Treated on Clinical Trial EST-1690

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 doctors predict how patients will respond to treatment.
  PURPOSE: This research study is looking at tumor tissue samples from patients with melanoma treated on clinical trial EST-1690.

Detailed description: OBJECTIVES:
  -  To validate the prognostic role of several biomarkers suggested by gene expression profiling and tissue microarray (TMA) studies (e.g., NCOA3, SPP1, and RGS1) on the outcome associated with melanoma in the EST-1690 cohort using IHC analysis.
  -  To examine the potential predictive role of such biomarkers in patients undergoing adjuvant interferon alfa therapy.
  -  To analyze the correlation between the intensity of biomarker expression and survival of this cohort both in the observation and in the interferon-treated groups.
  -  To examine the prognostic role of these biomarkers on the outcome associated with melanoma in the EST-1690 cohort using quantitative-PCR.
  -  To isolate RNA from the primary specimens from patients enrolled in the EST-1690 cohort to assess the expression of genes suggested by cDNA microarray and IHC analyses (e.g., NCOA3, SPP1, and RGS1) as prognostic or predictive markers.
  OUTLINE: Samples from the EST-1690 cohort are obtained and analyzed for several biomarkers (i.e., NCOA3, SPP1, and RGS1) via immunohistochemistry and quantitative PCR. RNA is isolated from the specimens to assess gene expression via quantitative PCR.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of melanoma
  -  No metastatic disease at diagnosis
  -  Treated on protocol EST-1690
  -  Primary tumor tissue specimens available
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: A Study of Tasisulam Versus Paclitaxel as Treatment for Metastatic Melanoma

Summary: The primary purpose of this study is to see how tasisulam affects metastatic melanoma when compared against paclitaxel as measured by overall survival.


Eligibility: Inclusion Criteria:
  -  Have a histologic and/or cytologic diagnosis of metastatic melanoma (Stage IV)
  -  Have the presence of evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0)
  -  Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group(ECOG) Scale
  -  Have progressed after 1 previous systemic treatment containing dacarbazine or temozolomide for metastatic melanoma
  -  Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia)
  -  Have a serum albumin level greater than or equal to 3.0 g/dL or greater than or equal to 30 g/L
  Exclusion Criteria:
  -  Have received greater than or equal to 2 previous chemotherapy-containing systemic treatment regimens for metastatic melanoma. An immunotherapy or antibody-based regimen [including biologic agents and vaccination-based treatments], or treatment with a targeted agent (e.g BRAF or c-Kit inhibitor, is not counted as a prior treatment regimen for determining study eligibility, unless either was combined with a cytotoxic drug).
  -  Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. Patients with a history of a solitary CNS metastasis previously treated with curative intent (e.g., stereotactic radiation or surgery) and not requiring steroids are eligible.
  -  Are receiving warfarin
  -  Have primary ocular or mucosal melanoma
  -  Any previous treatment with paclitaxel or a paclitaxel-containing regimen for metastatic melanoma
  -  Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator)
  -  Have previously completed or withdrawn from this study or any other study investigating tasisulam
  -  Have a known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil)
  -  Are pregnant or lactating
  -  Have received a recent (within 30 days before enrollment) or are receiving concurrent yellow fever vaccination
  -  Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb)
  -  Are unable to withhold dosing of non-steroidal anti-inflammatory drugs (NSAIDs) or proton-pump inhibitors (PPIs) for at least 72 hours before and after treatment with tasisulam.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

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: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma

Summary: This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage III or IV uveal melanoma who have not received prior immunotherapy. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 has been shown to induce durable tumor responses in patients with metastatic melanoma in phase 1 and phase 2 clinical studies.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed uveal melanoma including choroidal melanoma, iris melanoma, and ciliary body melanoma
  -  Patients may either have measurable disease or non-measurable disease.
  -  Biopsies from a readily accessible site of disease on study enrollment are mandatory in principle. Waivers will be granted if there are no accessible lesions. The collection of a representative block of the diagnostic tumour tissue (if available) is mandatory.
  -  ECOG performance status of 0 or 1
  -  Age 18 years or older
  -  Adequate bone marrow, hepatic, and renal function determined within 14 days prior to registration, defined as:
  -  Serum lactic acid dehydrogenase (LDH) </= 1.5 x ULN.
  -  Alkaline phosphatase (ALP) </= 2 x ULN.
  -  No weight loss >/= 10% in the proceeding 4 weeks.
  -  CT scan of the brain with contrast or MRI of the brain within 28 days of registration showing no evidence of brain metastases.
  -  Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
  -  Females of childbearing potential and males who have not undergone surgical sterilization must agree to practice a form of effective contraception prior to entry into the study and for 12 months following the last dose of study drug. The definition of effective contraception will be based on the judgment of the investigator.
  Exclusion Criteria:
  -  Melanoma of cutaneous, mucosal or conjunctival origin.
  -  History of brain or leptomeningeal metastases.
  -  Received any prior CTLA4 inhibiting agent (eg MDX-010, ipilimumab) or other immunotherapy.
  -  History of chronic inflammatory or autoimmune disease
  -  History of uveitis or melanoma-associated retinopathy.
  -  History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.
  -  History of hepatitis due to Hepatitis B virus or Hepatitis C virus

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi

Summary: A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions and melanoma is developed. Goals include evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the identification of high-risk lesions and melanomas.


Eligibility: Inclusion Criteria:
  -  Patients seen in the high-risk pigmented lesion clinic, who posses a pigmented lesion with a clinical indication for biopsy
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

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: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: A Safety and MORAb-028 Dose Determination Study in Subjects With Metastatic Melanoma

Summary: The purpose of this study is to evaluate whether therapy with MORAb-028 is safe, effective, and to determine the appropriate dose of MORAb-028 in the treatment of metastatic melanoma.

Detailed description: Melanoma is a serious form of skin cancer. If untreated, the melanoma can spread beyond the original affected tissue and invade distant tissue and organs. Treatment for metastatic melanoma includes medical treatments (chemotherapy or immunotherapy), surgery, or radiation therapy. MORAb-028 is a recombinant human immunoglobulin M (IgM) monoclonal antibody that recognizes a cell surface diacyl ganglioside named disialoganglioside (GD2). GD2 is overexpressed in tumors of neuro-ectodermal origin such as melanomas, neuroblastomas, small-cell lung carcinomas, and many sarcomas, while absent in most normal tissues. GD2 expression has been demonstrated in human melanoma and small cell lung cancer by thin layer chromatography and radiolabeled anti-GD2 antibody detection. It is hypothesized that one mode of action of MORAb-028 is complement-dependent cytotoxicity. Complement-dependent cytotoxicity is a mechanism for killing tumor cells in which an antibody bound to the target cell surface fixes complement, which results in assembly of the complement membrane attack complex that punches holes in the target cell membrane resulting in subsequent cell lysis. IgMs strongly bind to C1Q and robustly activate complement-dependent cytotoxicity. MORAb-028 is being developed as a potential therapy for GD2-positive tumors.

Eligibility: Inclusion Criteria:
  -  Measurable metastatic melanoma that has failed standard therapy
  -  Males and females greater than or equal to 18 years of age
  -  Life expectancy of greater than or equal to 3 months
  Exclusion Criteria:
  -  Significant cardiovascular impairment
  -  Clinically significant illness, medical condition, surgical history, or laboratory abnormality that could affect the safety of the subject or negatively impact the study results
  -  Chemotherapy, radiotherapy, or immunotherapy within 3 weeks prior to administration to MORAb-028

Relevance to patient case: not relevant