araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

Summary: The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib.
  -  To determine the time to progression.
  Secondary
  -  To correlate c-kit mutational status with response to therapy.
  -  To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
  -  Tolerability of imatinib.
  -  To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.
  -  To correlate c-kit amplification status with response to therapy.

Eligibility: Inclusion Criteria:
  -  Melanomas that arise on chronically sun damaged skin and have pathologic evidence of solar elastosis
  -  History of primary mucosal or acral/lentiginous melanoma
  -  Histologically documented stage IV metastatic melanoma
  -  ECOG performance status 0,1, or 2
  -  Estimated life expectancy of 6 months or greater
  -  Age 18 years or older
  -  Creatinine < 1.5 x ULN
  -  ANC > 1500 ul
  -  Platelets > 100,000 ul
  -  Total bilirubin, AST, and ALT < 2 x ULN
  -  Amylase and lipase < 1.5 x ULN
  -  C-kit mutation documented from either primary or metastatic tumor site
  -  > 4 weeks from prior chemotherapy or investigational drug
  -  At least one measurable site of disease as defined by at least 1 cm in greatest dimension
  Exclusion Criteria:
  -  Severe and/or uncontrolled medical disease
  -  Pregnant or nursing mothers
  -  Any other significant medical, surgical, or psychiatric condition that my interfere with compliance
  -  Patient is < 5 years free of another primary malignancy except: basal cell skin cancer or a cervical carcinoma in situ
  -  Concurrent treatment with Warfarin
  -  Prior treatment with c-kit inhibitor
  -  Patient with Grade III/IV cardiac problems as defined by NYHA criteria
  -  No H2 blockers or proton pump inhibitors
  -  Known brain metastasis
  -  Known chronic liver disease
  -  Known diagnosis of HIV infection
  -  Previous radiotherapy to > 25% of the bone marrow
  -  Major surgery within 2 weeks prior to study entry
  -  Patient has received any other investigational agent within 28 days of first study drug dosing
  -  Chemotherapy within 4 weeks prior to study entry

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Summary: The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that uses machine vision for non-invasive early detection of cutaneous pigmented malignant melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with illumination in different spectral bands, from visible to near infrared, and automatically analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will be evaluated. The reference standard will be final interpretation of lesions by central dermatohistopathology.


Eligibility: Inclusion Criteria:
  -  The lesion is pigmented (i.e., melanin, keratin, blood)
  -  Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion
  -  The diameter of the pigmented area is between 2 and 22 millimeters
  -  The lesion is accessible to the MelaFind hand-held imaging device
  -  The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form
  Exclusion Criteria:
  -  The patient has a known allergy to isopropyl alcohol
  -  The lesion has been previously biopsied, excised, or traumatized
  -  The skin is not intact (e.g., open sores, ulcers, bleeding)
  -  The lesion is within 1 cm of the eye
  -  The lesion is on mucosal surfaces (e.g., lips, genitals)
  -  The lesion is on palmar hands
  -  The lesion is on plantar feet
  -  The lesion is on or under nails
  -  The lesion is located on or in an area of visible scarring
  -  The lesion contains foreign matter (e.g., tattoo, splinter, marker)

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Study of Families With Melanoma

Summary: RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse.
  PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.

Detailed description: OBJECTIVES:
  Primary
  -  Determine what lifestyle factors and which genes govern relapse from melanoma.
  Secondary
  -  Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants.
  -  Assess how unusual moles relate to sun exposure and genes that cause melanoma.
  OUTLINE: This is a multicenter, cohort study.
  Patients and healthy participants complete lifestyle questionnaires by mail and telephone. Some patients* and healthy participants undergo a skin examination to count moles and classify skin type (e.g., degree of freckling and wrinkling indicative of sun damage).
  NOTE: *Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination.
  Patients and healthy participants also undergo blood collection for lymphocyte analysis, DNA extraction, and the measurement of minerals, vitamins, and beta carotene. Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations, including CDKN2A and CDK4.
  Patients and healthy participants are followed annually.
  Peer reviewed and funded or endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 3,700 patients and healthy participants will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Newly diagnosed primary invasive melanoma (patient group)
  -  Lentigo maligna malignant melanoma allowed
  -  Rare variants of melanoma allowed, including any of the following:
  -  Acral lentiginous
  -  Subungual
  -  Ear, nose, and throat
  -  Oropharyngeal
  -  Perineal
  -  Vaginal
  -  Vulval
  -  Rectal
  -  Nodal with no known primary
  -  Patients undergoing sentinel node biopsy are eligible
  -  No in situ melanoma, melanocytic intraepidermal neoplasia, or ocular melanoma
  -  Healthy participant meeting either of the following criteria (control group):
  -  Relative of a patient who was diagnosed with melanoma after September 2005
  -  Healthy volunteer who is age- and sex-matched for patients who were diagnosed with melanoma before October 2005
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Expression of NIS Protein and mRNA in Thyroid Tumors

Summary: The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was overexpressed in thyroid cancer. The aim of this study was to investigate the NIS transcript levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16 malignant) and in their surrounding non-tumoral tissues (NT), by real time RT-PCR and immunohistochemistry, respectively. Our results revealed lower gene expression in 78.6% of the benign tumors and 100% of the carcinomas when compared with the NT samples, using GHPDH as a housekeeping gene. Immunohistochemical staining revealed presence of NIS protein in 100% of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. NIS protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of benign and 12.5% of malignant tumors. Stronger cytoplasmatic immunostaining of NIS protein was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to NT. Association between low gene expression and strong cytoplasmatic immunostaining was found in 50% of benign tumors and 87.5% of malignant tumors. We concluded that the reduced NIS gene expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to its incapacity to migrate to cellular membrane.

Detailed description: The aim of this study was to quantify NIS transcript levels by real time PCR and to determine the presence and cellular localization of NIS protein by immunohistochemistry, in benign and malignant thyroid tumor cells and to compare with their paired surrounding non-tumoral cell. NIS expression was also compared to that of the TSHR

Eligibility: Inclusion Criteria:
  -  PAtients with thyroid tumors undergoing surgery for total or partial thyroidectomy
  Exclusion Criteria:
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: High-resolution Magnetic Resonance Imaging (MRI) Scans to Look for Spread of Melanoma to Nearby Lymph Nodes

Summary: The study is designed to see if a high-resolution MRI scan of lymph node areas near where a melanoma has been removed from the skin can pick up the spread of melanoma to those lymph nodes with a high degree of accuracy.

Detailed description: When a melanoma of the skin is diagnosed, there is some chance it can spread to nearby lymph nodes, and from there to other parts of the body. Currently, patients with melanoma at low risk for spreading to lymph nodes do not get the lymph nodes assessed except by a physical exam. Those at high risk for spreading to lymph nodes get one or more lymph nodes removed surgically to check for melanoma spread. But physical exam alone will often miss small areas of melanoma in lymph nodes; removal of lymph nodes by surgery is painful and can cause complications. Neither assessment tool is optimal.
  This study is designed to see if use of very high-resolution contrast-enhanced MRI scans of lymph node areas near the primary melanoma site in the skin can accurately detect small areas of melanoma spread to those lymph nodes. If this turns out to be the case, in the future, MRI scans could potentially be an alternative for assessing lymph nodes, compared to physical exams alone or surgical removal of the lymph nodes.
  In this study, patients with low risk melanoma will receive very high-resolution MRI scans of nearby lymph nodes every 6 months for 5 years of follow-up. If the MRI looks abnormal, the lymph nodes will be biopsied, and results from the biopsy compared to the results from the MRI.
  Patients with high risk melanoma will get a baseline MRI of the nearby lymph nodes, and then one or more lymph nodes will be removed (usually by sentinel lymph node biopsy) regardless of the MRI results. Again, results from the biopsy will be compared to the results from the MRI. MRI's will still be repeated every 6 months to assess whether lymph nodes not removed at surgery develop any changes.
  We plan to enroll 200 patients on this study and by the end of the study will have a measure of the sensitivity and specificity of high-resolution MRI scans in the detection of melanoma involvement of regional lymph nodes.

Eligibility: Inclusion Criteria:
  -  history of invasive cutaneous melanoma stages 1-3 within 2 years of treatment of the melanoma by primary excision
  -  eligible whether or not a sentinel lymph node biopsy or regional lymph node dissection has been performed
  -  adequate renal function (creatinine 2 or less)
  -  life expectancy 2 years of more
  Exclusion Criteria:
  -  history of severe claustrophobia precluding MRI scans
  -  known hypersensitivity or other contraindication to gadolinium contrast
  -  known presence of metastatic melanoma at sites beyond regional lymph nodes (stage 4)

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma

Summary: RATIONALE: Cytotoxic T lymphocytes (CTL) are cells of the immune system that can fight infections and cancer. These CTL can be manipulated in the laboratory so that they can target an individual's cancer.
  PURPOSE: This early phase trial is studying the feasibility and side effects of intravenous infusions of CTL generated in the laboratory. To produce the CTL, the study participant's own immune cells are collected by a procedure called a leukapheresis. The cells then undergo laboratory processing for three weeks. Part of this processing includes mixing the patients immune cells with a new kind of cell that has some extra genes added to it. These extra genes are to "teach" the participant's own immune cells to become anti-tumor CTL that can attack the melanoma.

Detailed description: DETAILED OUTLINE: This is an early phase pilot/feasibility trial.
  Study subjects will be sequentially accrued to three cohorts. Cohorts 1 and 2 will evaluate the safety and feasibility of infusing two different doses of CTL.
  -  Participants in all cohorts will undergo two CTL infusions 5 weeks apart.
  -  Procedures performed during the trial will include physical examinations, laboratory tests, delayed hypersensitivity testing, and skin biopsies.
  -  Between 5 and 8 days after the first CTL infusion, a biopsy or excision of a melanoma lesion may be performed.
  -  Three leukapheresis procedures will be performed: two to collect peripheral blood for CTL production and one for research purposes at the end of the clinical trial.
  -  Radiology tests (including CT scans) will be performed prior to infusion and about 4-5 weeks after the second CTL infusion.

Eligibility: Inclusion Criteria:
  -  Patients with metastatic melanoma: Either unresectable Stage III or any Stage IV
  -  ECOG of 0 or 1
  -  HLA-A*0201 haplotype
  -  Baseline tumor biopsy MART1/Melan-A expression present (in >10% of tumor cells)
  -  Patient provides consent for all required biopsies
  -  Adequate intravenous access for leukapheresis
  -  Absolute lymphocyte count >500/ul at least once within 30 days of leukapheresis
  -  Life expectancy greater than 4 months in the opinion of the study clinician
  -  Negative pregnancy test
  Exclusion Criteria:
  -  Administration of systemic corticosteroids within 28 days of planned leukapheresis
  -  Administration of cytotoxic chemotherapy or anti-tumor immunotherapy within 28 days of planned leukapheresis
  -  Administration of radiotherapy within 28 days of planned leukapheresis with the exception of subjects accrued to Cohort 3
  -  Active autoimmunity requiring systemic immunosuppressive therapy
  -  HIV infection
  -  Previous enrollment on this protocol and infusion of MART1/Melan-A CTL

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: MicroRNA Expression and Function in Cutaneous Malignant Melanoma

Summary: Spectrophotometric intracutaneous analysis (SIAscopy) is a new technique for imaging pigmented skin lesions and for diagnosing melanoma and non-melanoma skin cancer. The SIAscope is a portable system comprising of a laptop computer connected to a small handheld skin probe equipped with a light source. The skin lesion is interrogated with light of different wavelengths and the reflection spectra analysed by proprietary algorithms showing distribution, position and quantity of melanin, blood and collagen within the papillary dermis (the SIAgraphs). Earlier studies generated promising results and documented >80% specificity and sensitivity of SIAscopy for melanoma diagnosis. It has been suggested that this technique could be used for the initial screening and selection of pigmented lesion for excision. In this work we addressed the usefulness of SIAscopy for the clinical diagnosis of pigmented malignant melanoma in a prospective, blinded design.


Eligibility: Inclusion Criteria:
  -  Pigmented lesion
  Exclusion Criteria:
  -  No pigmented lesion

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

Summary: Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.

Detailed description: The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly.
  Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).

Eligibility: Inclusion Criteria:
  -  Histologic diagnosis of cutaneous or mucosal melanoma, soft tissue sarcoma (STS), or an APUD (amine precursor uptake and decarboxylation) tumor. APUD tumors include parathyroid carcinoma, medullary carcinoma of the thyroid, small cell carcinoma of the lung, pheochromocytoma, islet cell tumors, carcinoid tumors, and malignant paraganglioma.
  -  Measurable or evaluable disease not appropriate for resection and/or radiation with curative intent. Patients with small cell carcinoma must have extended stage disease or, if limited stage disease, must have received at least one prior systemic therapy.
  -  Age 18 years or greater
  -  ECOG Performance Status 0 or 1
  -  Women must be post-menopausal, infertile as the result of a surgical procedure, or willing to use a medically accepted form of birth control (abstinence, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condon with spermicide) for the duration of study treatment. Men also must agree to use a medically accepted form of birth control for the duration of study treatment.
  Exclusion Criteria:
  -  Uncontrolled brain metastatic disease
  -  Platelet count <100
  -  Absolute neutrophil count <1.5
  -  Blood transfusion or hematopoietic growth factors for cytopenia within one month of enrollment.
  -  Calculated or measured (Cockcroft and Gault formula) creatinine clearance <30 mL/minute
  -  AST > 3 times the upper limit of normal, unless elevation due to metastatic disease, in which case AST > 5 times the upper limit of normal
  -  Bilirubin > 2 mg/mL
  -  Grade 2 or greater peripheral neuropathy
  -  Hypersensitivity to bortezomib, boron, mannitol, or dacarbazine
  -  Pregnant or nursing
  -  Other investigational drugs within 14 days of enrollment
  -  Other medical or other condition(s) that in the opinion of the investigator/sub-investigator might compromise the objectives of the study

Relevance to patient case: not relevant
Patient case: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Phase II, 2nd Line Melanoma - RAND Monotherapy

Summary: The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks


Eligibility: Inclusion Criteria:
  -  Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease, and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvant and/or neoadjuvant therapy, the subject must have documented disease progression from the last treatment and also received one additional line of systemic therapy for metastatic disease.
  -  Men and women, who are at least 18 years of age
  Exclusion Criteria:
  -  Ocular or mucosal melanoma
  -  Complete surgical resection of all identifiable sites of disease
  -  Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by computerized axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable brain metastasis and those who were previously treated with radiotherapy or surgery must have no current evidence of symptomatic brain metastasis and are off steroid therapy for at least 4 weeks prior to randomization

Relevance to patient case: not relevant