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

Clinical trial: Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes

Summary: The goal of this clinical research study is to learn if the combination of Gleevec (imatinib mesylate) and low doses of Cytarabine (ara-C) may help to control leukemia while causing fewer side effects than standard high dose chemotherapy.

Detailed description: Imatinib mesylate is a drug that blocks a certain protein. This protein is thought to be important in the growth of leukemia cells. Ara-C is a chemotherapy drug that has been used for many years to treat AML and MDS.
  Imatinib mesylate (Gleevec) is a protein-tyrosine kinase inhibitor that inhibits the Bcr-Abl tyrosine kinase, as well as the receptor tyrosine kinases for platelet- derived growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events. c-Kit is expressed in over 90% of patients with AML.
  The treatment of AML for patients age 65 or older with AML or high-risk MDS (age ³ 60 if high-risk cytogenetics) have a poor prognosis with induction chemotherapy. Response rate is no more than 45% with an induction mortality of at least 25%, and 1-year survival no better than 20%. Indeed, most patients in these age groups are not even offered therapy and are managed with supportive care only. Thus, new therapies that are better tolerated are needed.
  Imatinib alone can induce response in nearly 20% of patients, and there is synergy with low concentrations of ara-C. In this study we plan to investigate the combination of imatinib and low-dose ara-C.

Eligibility: Inclusion Criteria:
  -  Patients who are not candidates for intensive chemotherapy with any of the following diagnosis: 1. AML or MDS (with >/=5% blasts) age >/= 65 years old (or age >/= 60 if high-risk cytogenetics), or 2. AML or MDS (RAEB or RAEBT) of any cytogenetic group age 60 or older with minimally treated disease who have relapsed disease or are refractory to therapy and not likely to require cytoreductive therapy within one month, and, or 3. CMML.
  -  Patients with WHO performance status of 0 to 2
  -  Patients must have recovered from prior cytotoxic chemotherapy; treatment with hydrea is allowed up to 24 hours prior to day 1 of study drug administration
  -  Written informed consent obtained according to local guidelines
  -  Patients must have a serum creatinine of </= 1.5 x ULN, SGPT </= 3 x ULN and total bilirubin </= 2.0 x ULN.
  -  Patients with >/= 20% blasts positive for c-kit (CD117) (except for CMML)
  -  Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of childbearing potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
  Exclusion Criteria:
  -  Patients with uncontrolled active infection
  -  Patients with NYHA class III or IV
  -  Women who are pregnant
  -  Women who are breast feeding

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

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: 62-year-old female with melanoma; genetic feature: KIT (K642E)

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: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine

Summary: This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense


Eligibility: Inclusion Criteria:
  -  Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
  -  ECOG Performance Status of 0, 1, or 2
  -  Life expectancy of at least 12 weeks
  -  Adequate venous access
  -  Agreement to practice effective method of birth control
  Exclusion Criteria:
  -  Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy
  -  Significant medical disease
  -  Known hypersensitivity to phosphorothioate-containing oligonucleotides
  -  Known hypersensitivity to DTIC
  -  Pregnancy/Lactation

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

Clinical trial: A Model for Genetic Susceptibility: Melanoma

Summary: The goal of this study is to find out if some people are more likely to get melanoma, a form of skin cancer, than others are. To do this we will compare people who have had more than one melanoma to people who have had only one melanoma and to people who are similar but who have not developed melanoma.
  People respond to the environment in different ways. Some may be born with genes that make them more likely to get this type of skin cancer. Each person has many ways to repair normal damage to their genes. Specific genes may affect the repair of sun damage. Other genes affect the way the skin itself reacts to the sun. We want to find out which genes have normal changes in them and lead to different responses to exposures, such as the sun. We also want to find out if sun habits are related to the way these genes work.

Detailed description: The purpose of this study is to better understand genetic susceptibility to melanoma and the interactions of specific polymorphisms with each other and with environmental factors.
  To accomplish this, buccal swabs or blood specimens from patients with melanoma (either single primary or multiple primary) have been collected. Specimens will be prepared in the Epidemiology Laboratory at MSKCC. They will be analyzed at MSKCC for INK4A (and functional assays for DNA repair capacity when blood is available) and the melanocortin gene (MC1R), at the University of North Carolina for polymorphisms in DNA repair genes and immune function genes, at the University of Pennsylvania for polymorphisms in the melanocortin receptor gene (MC1R) and immune function genes, and at the University of California (Irvine) for polymorphisms in metabolizing genes (P450's and GST's). Samples will be banked at MSKCC and the University of New Mexico. In order to perform this study, subjects from population-based registries in the United States (New Jersey, North Carolina, Michigan, San Diego/Imperial Counties), Canada (Cancer Care Ontario, British Columbia), Italy (Turin), Australia (New South Wales, Tasmania), were interviewed, asked to provide blood or buccal swab samples and asked to provide permission to obtain and review slides of their primary melanoma. This study is now closed to accrual.

Eligibility: Inclusion Criteria:
  - The subject must have a histologically confirmed invasive first primary melanoma newly diagnosed between January 1, 2000 and December 31, 2000.
  OR the subject must have a histologically confirmed invasive or in situ second primary melanoma newly diagnosed between January 1, 1998 and December 31, 2003. One of the earlier primaries must be invasive melanoma OR the subject must be a randomly ascertained control from the general.
  - The patient must be a resident of a one of the specific geographic areas participating in this study.
  Exclusion Criteria:
  -  Subjects who do not speak English or Italian
  -  Subject is unable to sign informed consent
  -  Subject is unable to participate in telephone interview

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

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: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

Summary: The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.


Eligibility: Inclusion Criteria:
  -  Diagnosed with acute hepatitis C virus (HCV).
  -  Normal and Elevated serum alanine transferase (ALT) levels
  -  Positive serum HCV-RNA.
  -  Aged between 18 and 65 years.
  -  Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion
  Exclusion Criteria:
  -  Liver disease unrelated to HCV infection
  -  Hemoglobin (Hgb) <12g/dL in women and <13g/dL in men; white blood cells (WBC) <3,000/uL; platelets (PLTs) <100,000/ul
  -  Women with ongoing pregnancy or who are breast feeding
  -  History of severe psychiatric disease, especially depression
  -  History of neurologic disease, especially epilepsy
  -  History or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
  -  Positive anti-Human Immunodeficiency Virus (HIV) antibodies
  -  Positive anti-nuclear antibodies (ANA) and/or Anti-Smooth Muscle Antibody (ASMA) (>1/80)
  -  Positive Hepatitis B surface antigen (HBsAg)
  -  History of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months
  -  History or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)

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

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: 62-year-old female with melanoma; genetic feature: KIT (K642E)

Clinical trial: Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

Summary: RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to the disease.
  PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with relapsed or progressive systemic mastocytosis.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the objective response rate at 6 months in patients with systemic mastocytosis treated with thalidomide.
  Secondary
  -  Determine the tolerability of this drug in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive oral thalidomide once daily for 6 months in the absence of disease progression.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of systemic mastocytosis
  -  Aggressive or borderline (smoldering) disease (in first line or more)
  -  Relapsed or progressive disease
  -  Measurable or evaluable disease
  -  Presence of c-Kit D816V mutation in the skin, spine, or infiltrated organs
  -  No nonsymptomatic mastocytosis
  PATIENT CHARACTERISTICS:
  -  Life expectancy > 3 months
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception for 1 month prior to, during, and until first menstrual cycle after completion of study treatment
  -  Bilirubin < 2 times normal (unrelated to disease)
  -  Liver enzymes < 2 times normal (unrelated to disease)
  -  Creatinine ≤ 300 mmol/L
  -  No central or peripheral neuropathy leading to psychiatric concerns
  -  No HIV positivity
  -  No active infection or other serious underlying illness that would preclude treatment
  -  No history of thromboembolism or deep vein thrombosis
  -  No geographical, social, or psychological reasons preventing medical monitoring
  PRIOR CONCURRENT THERAPY:
  -  More than 4 weeks since prior antitumor therapy (e.g., chemotherapy, radiotherapy)
  -  No other concurrent treatment specific for this disease
  -  No concurrent participation in another experimental drug trial

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

Clinical trial: Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year

Summary: This study is a 1 year review of all patients who had surgery to correct pelvic organ prolapse (i.e. cystocele, rectocele, enterocele) using the Avaulta synthetic mesh kit.

Detailed description: This is a retrospective cohort analysis of all patients who experienced vaginal prolapse and were operated on with the Avaulta synthetic vaginal mesh "kit" from January 2006 to April 2007. The Avaulta synthetic mesh is composed of polypropylene which is a monofilament. The objective of this trial is to compare patients objectively and subjectively at least one year after placement of the Avaulta synthetic vaginal mesh in terms of prolapse symptoms.
  This data will be compared to pre-operative data already collected for these patients as a part of their routine surgical work-up. Mesh-related complications will be quantified, including erosions, new-onset pain, and infections. Success and anatomic recurrence rates will be recorded as well

Eligibility: Inclusion Criteria:
  -  All patiAll patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08.
  Exclusion Criteria:
  -  Unable to give informed consent to participate

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

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