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: Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases

Summary: To assess the response of melanoma with brain metastases to ipilimumab treatment while maintaining acceptable tolerability.


Eligibility: Key inclusion criteria
  -  Histologically confirmed malignant melanoma
  -  At least 1 measurable index brain metastasis >0.5 cm and no larger than 3 cm in diameter that had not been previously irradiated, and/or 2 measurable lesions >0.3 cm visible on contrast magnetic resonance
  -  Index brain lesion must have resolved consequences of prior therapy that could have confounded attribution of tumor response including edema and hemorrhage
  -  Participants in ipilimumab monotherapy arm (including the first 21 who were enrolled in Stage 1) were to be free of neurologic symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy in the 10 days prior to beginning ipilimumab therapy
  -  Eastern Cooperative Oncology Group performance status of 0 or 1
  -  Required values for initial laboratory tests:
  -  White blood cell count ≥2000/μL
  -  Absolute neutrophil count ≥1000/μL
  -  Platelets ≥100*10^3/μL
  -  Hemoglobin level ≥9 g/dL (may have been transfused)
  -  Aspartate aminotransferase/alanine aminotransferase (AST/ALT) level ≤2.5*ULN for participants without liver metastasis
  -  AST/ALT level ≤5*ULN for those with liver metastasis
  -  Bilirubin level ≤2*ULN (except participants with Gilbert's Syndrome, who must have had a total bilirubin level less than 3.0 mg/dL)
  -  Age 16 years and older
  -  Males and females
  -  Women of childbearing potential (WOBP) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal.
  Key exclusion criteria
  -  History of carcinomatous meningitis, with prior stereotactic or highly conformal radiotherapy and/or whole brain irradiation within 14 days before the first dose of ipilimumab, and documented history of autoimmune disease
  -  Prior stereotactic or highly conformal radiotherapy and/or whole brain irradiation within 14 days prior to start of ipilimumab dosing for this study. Note the stereotactic radiotherapy field must not have included the brain index lesion or the lesion must have been detected and confirmed to be active and progressing after receiving whole brain irradiation.

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: 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: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

Summary: RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma.
  PURPOSE: This early phase I trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that can be removed by surgery.

Detailed description: OBJECTIVES:
  Primary
  -  To evaluate the potential effects of glutamate receptor blockade on cellular pathways important in the genesis and progression of melanoma in patients with stage III or IV melanoma undergoing surgical resection.
  -  To determine whether treatment with riluzole alters expression of activated PLC and ERK in lysates from tumor tissue biopsies.
  Secondary
  -  Determine if treatment with riluzole affects the overall metabolic activity of melanoma tumors as measured by pre- and post-treatment PET scanning, pre- and post-treatment tumor mitotic rate evaluation, and pre- and post-treatment immunohistochemical staining for Ki-67.
  OUTLINE: Patients receive oral riluzole twice daily for 14 days. Within 24 hours after the final dose of riluzole, patients undergo standard surgical resection.
  Patients undergo tumor tissue sample collection at baseline and during surgery for laboratory studies. Samples are analyzed by routine histology, immunohistochemistry, western blotting, and RT-PCR for Grm1 expression, - RAS and B-raf mutations, PLC and MAP kinase activity, Ki-67 staining, and mitotic rate. Patients also undergo blood sample collection periodically for pharmacokinetics studies.
  PET scans are obtained before and after treatment to evaluate the overall metabolic activity of the tumor and how this activity changes with inhibition of the Grm1 pathway.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed melanoma
  -  Stage III or IV disease
  -  Must have at least two resectable tumors or a tumor large enough to undergo pre-treatment core needle biopsy
  -  Must be eligible for resection of disease with curative or palliative intent
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0 or 1
  -  ANC ≥ 1,000/mm³
  -  Platelet count ≥ 50,000/mm³
  -  AST/ALT ≤ 3 times upper limit of normal (ULN)
  -  Total bilirubin normal
  -  Calculated creatinine clearance ≥ 50 mL/min
  -  INR ≤ 25% of ULN
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for 48 hours after completion of study treatment
  -  No history of allergic reaction to riluzole or similar compounds
  -  No known history of hepatitis B or C
  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: A Phase II Study of an Anti-Tumor Immunotherapy Regimen Comprised of Pegylated Interferon-Alpha 2b and HyperAcute Melanoma Vaccine for Subjects With Advanced Melanoma

Summary: The purpose of this study is to determine the safety of giving subjects with advanced, recurrent or refractory melanoma the HyperAcute® Melanoma vaccine with a variant of a drug, called Interferon (PEG-Intron®) that is specially formulated to be given on a weekly basis (instead of daily). The study vaccine (HyperAcute®-Melanoma) is made from three types of human melanoma cell lines (grown in the laboratory) in which the genes have been slightly changed. This clinical study will try to discover the safety of the study vaccine combined with PEG-Intron®, its side effects and the potential benefits, if any.

Detailed description: This study will look at the anti-tumor vaccine effect, side effects and toxicity of the HyperAcute® Vaccine with PEG-Intron®. It is hoped that the immune system's response to these genetically engineered melanoma cells and PEG-Intron® will cause a reaction that will make it react to and attack and kill the melanoma cells and keep it from growing, possibly causing the tumors to shrink.
  Patients that are eligible are 19 years or older and have been diagnosed with advanced, treatment resistant or recurrent melanoma, an aggressive usually pigmented form of skin cancer.

Eligibility: Inclusion Criteria:
  -  19 years or older
  -  Histological diagnosis of melanoma
  -  AJCC Stage IIIC (any T, N1b, N2b, N3, M0) or Stage IV (any T, and N, M1), metastatic, progressive, refractory, recurrent or high risk of recurrence melanoma.
  -  Expected survival of more than 6 months
  -  Adequate organ function
  -  Measurable or non-measurable disease
  -  Must have negative serologies for Hepatitis B and C and HIV prior to entering study
  -  Must be more than 4 weeks since major surgery, radiotherapy, chemotherapy or biotherapy/targeted therapies
  -  Male and female subjects of child producing potential must agree to use contraception or avoidance pregnancy measures while enrolled on the study and for one month after the last immunization.
  Exclusion Criteria:
  -  Active CNS metastases or carcinomatous meningitis
  -  Hypercalcemia
  -  Pregnant or nursing women
  -  Other malignancy within five years
  -  History of organ transplant or current active immunosuppressive therapy
  -  Subjects taking systemic corticosteroid therapy
  -  Active infection or antibiotics within 1-week prior to study
  -  Uncontrolled or significant congestive heart failure, myocardial infarction, ventricular arrhythmias or pulmonary dysfunction
  -  Autoimmune disease
  -  A known allergy to any component of the HyperAcute vaccine or PEG-Intron
  -  Patients having undergone splenectomy
  -  Patients with sickle-cell anemia or thalassemia major.

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 Genes and the Environment in Patients With Endometrial Cancer in the East Anglia, Oxford, 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 to cancer and interactions between genes and the environment in patients with endometrial cancer.

Detailed description: OBJECTIVES:
  -  To obtain epidemiological information and biological material on a population-based series of endometrial cancer cases.
  -  To define the proportion of endometrial cancer incidence attributable to mutations in known predisposing genes such as MSH2 and MLH1.
  -  To determine the risk associated with these predisposing mutations by examining the cancer risk in relatives of patients who are shown to be carriers.
  -  To examine the effect of nongenetic risk factors in mutation carriers.
  -  To determine the pathological and clinical characteristics of endometrial cancers occurring in mutation carriers as compared with that in noncarriers.
  -  To establish whether mutations at other loci may predispose to endometrial cancer by comparing the frequency of alterations in endometrial cancer patients with the corresponding frequency in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.
  OUTLINE: This is a multicenter study.
  Patients complete an epidemiological questionnaire. The questionnaire will request identifying information about the patient's first-degree relatives.
  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 endometrial cancer patients recruited for this study, patients with breast, ovarian, prostate, 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-PROSTATE, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of endometrial cancer within the past 5 years
  -  Identified in any of the following geographic regions of the United Kingdom:
  -  East Anglia
  -  Oxford
  -  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: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

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: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

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: 48-year-old female with melanoma; genetic feature: tumor cells with >50% membranous PD-L1 expression

Clinical trial: Identification of Gene Biomarkers in Aging Skin

Summary: This study is a blinded, prospective, single-center, clinical study conducted in Japanese female subjects between the ages of 20-75 years. This design uses skin biopsy samples from environmentally exposed areas and unexposed (control) areas within the same subjects to assess the gene expression profile from three different age groups.

Detailed description: The primary objective of the skin aging study is to investigate changes in gene expression patterns that occur during the aging process.

Eligibility: Inclusion Criteria:
  -  Individuals who are willing to read and sign an informed consent form prior to participating in the study.
  -  Individuals who have a temperature of less than or equal to 100 degrees F at the time of biopsy collection.
  -  Individuals who had not applied any sunless tanning product on the arms within the past year.
  -  Individuals with no prior history of alcoholism (or who consume fewer than 2 to 3 alcoholic beverages per day).
  -  Individuals who have not consumed any anti-aging nutritional supplements (multivitamins and multiminerals are acceptable) or aspirin, NSAIDS, or other pain medication in the last 48 hours before biopsy.
  Exclusion Criteria:
  -  Male gender
  -  Individuals who did not fit the 'inclusion criteria' above.

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: Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma

Summary: RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer, and may help doctors learn how well patients will respond to treatment.
  PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon therapy in patients with melanoma.

Detailed description: OBJECTIVES:
  -  Generate a comprehensive multiplexed array of melanoma-associated serological markers and validate it using serum samples from patients with melanoma and healthy control participants.
  -  Determine changes in the profile of serological markers induced by interferon-alfa 2b (IFN-α2b) therapy.
  -  Define panels of serological markers with prognostic and predictive power for IFN-α2b therapy responses in patients with melanoma.
  OUTLINE: This is a multicenter study.
  Serum samples are used for multiplex analyses. Biomarkers to be assessed include cytokines, chemokines, growth factors, angiogenic and antiangiogenic molecules, matrix metalloproteases (MMPs), tissue inhibitors of MMPs (TIMPs), melanoma-associated antigens, basic fibroblast growth factor, insulin-like growth factor I and II, thrombospondin, endostatin, angiostatin, vasostatin, and vascular endothelial growth factor inhibitor.
  PROJECTED ACCRUAL: A total of 1,716 samples will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of melanoma OR healthy volunteer (control)
  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: 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