araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma

Summary: This project seeks to understand differences in the serum vitamin D levels and immune status in cutaneous malignant melanoma patients with different UV exposure histories in New Mexico.

Detailed description: It is well established that ultraviolet radiation (UV) exposure is related to the development of melanoma. There is also evidence that immune reactions are altered after UV exposure in the skin (locally) and perhaps throughout the body (systemically). Additionally, while the role of vitamin D and melanoma development has not been fully established, UV-B exposure is essential for vitamin D production in the skin. Increased sun exposure is also related to the presence of solar elastosis, which might protect (1) or improve survival from melanoma. Thus, melanoma represents a unique model for studying UV exposure, the immune system, and vitamin D. Malignant melanoma is an antigenic cancer; therefore, the role of UV exposure-induced immunosuppression and vitamin D production in the recognition, destruction and growth inhibition of cancerous melanocytes is worth further study.
  To underscore the importance of this project, the Scientific Advisory Committee of the Melanoma Research Foundation and the Steering Committee of the Society of Melanoma Research have indicated a need to collect more human data on the host immune response mechanisms in melanoma and also to focus on the skin as a whole microenvironment, moving away from only in vitro experiments.

Eligibility: Inclusion Criteria:
  -  Resident of New Mexico
  -  Age between the 1 and 95
  -  Newly diagnosed with cutaneous invasive melanoma; any stage permitted (ICDO C44.0-9) between September 1, 2008 and December 31, 2011.
  -  SSM (superficial spreading melanoma) and NM (nodular melanoma) histological subtypes are allowed
  -  Access to a telephone or be able to participate in a personal interview at the clinic
  -  Physically and mentally competent to complete a 1-hour telephone or personal interview
  Exclusion Criteria:
  -  Ocular melanoma, LMM (lentigo maligna melanoma) or ALM (acral lentigo melanoma), and mucosal melanoma cases.
  -  No access to a telephone or is not able to meet with the interviewer.

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

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: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma

Summary: The purpose of the study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel in subjects with Stage III (unresectable) and Stage IV melanoma.

Detailed description: All subjects will receive YM155 and docetaxel given in a 21-day cycle. The docetaxel dose will be established based on the findings of the lead-in portion of the study (Part 1). Once the docetaxel dose is established, Part 2 enrollment will begin.
  Part 1:
  Part 1 is a lead-in stage that will confirm if YM155 can be safely administered in combination with docetaxel at a specified dose.
  Part 2:
  Subjects enrolled in Part 2 will receive YM155 and docetaxel at the dose established during Part 1.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma
  -  No prior systemic treatment or Cytotoxic chemotherapy for advanced melanoma (Stage III or Stage IV)
  -  If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
  -  Eastern Cooperative Oncology Group (ECOG) performance status </= 1
  -  Life expectancy > 12 weeks
  -  At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors ({RECIST} version 1.1)
  -  Subjects with a previous history of non-melanoma malignancy must have undergone curative therapy for all prior malignancies and be considered disease free for at least 5 years
  Exclusion Criteria:
  -  Major surgery within 21 days of the Baseline Visit
  -  Presence or history of brain metastases
  -  Primary ocular, choroidal or mucosal melanoma
  -  Known history of positive test for Hepatitis B surface Antigen (HsbAg) or Hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
  -  Hypersensitivity to docetaxel or polysorbate 80
  -  Neuropathy greater than or equal to Grade 2 at Baseline Visit
  -  The subject has been previously treated with YM155
  -  Inadequate marrow, hepatic, and/or renal functions

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Survey Study - Sensitivity Comparison Between MelaFind and Physician Group

Summary: This survey study purposes to determine and compare the biopsy/referral sensitivity and specificity of MelaFind to the average biopsy/referral sensitivity and specificity of dermatologists. 241 subjects logged into system but only 183 signed consents and completed the intake survey. Out of these 183, 155 were accounted for in the data analysis after exclusions were removed from the pool of subjects.

Detailed description: Early detection of melanoma is critical for favorable prognosis, since patients with earlier stage melanomas have a much higher probability of survival than with later stages. The traditional method of early detection has been with serial total body skin exams where the health care provider examines all skin surfaces, including mucosa, for suspicious pigmented lesions. Studies have demonstrated that the diagnostic accuracy of physicians for melanoma depends on the level of dermatological training. More important than being able to make a diagnosis of melanoma on clinical impression is the ability to make an appropriate decision to biopsy the lesion. Primary care physicians (PCPs) are often expected to screen for melanoma and only refer to dermatologists when there is a high clinical suspicion of melanoma. However, if PCPs are not adept at diagnosing melanoma, then opportunities for early diagnosis and treatment could be missed. Conversely, the morphology of benign pigmented lesions can often mimic that of early melanomas, resulting in potentially unnecessary dermatology referrals, biopsies, and patient anxiety. Studies have indicated that there is great variability in the ability of PCPs to make a correct decision to biopsy/refer a pigmented lesion (1.5 times greater than dermatologists) as well as for diagnosing melanoma (over 2.5 times greater than dermatologists). To aid in detection of early melanomas, new technologies are being developed.
  One such technology is MelaFind, an investigational device that has been developed to give a recommendation for biopsy (or not) of pigmented skin lesions to rule out melanoma. Our hypothesis is that MelaFind will have equal or better sensitivity than pigmented lesion experts in making an appropriate recommendation for biopsy (i.e., MelaFind will be at least as accurate as dermatologists in recommending biopsy for melanomas).

Eligibility: Inclusion Criteria:
  -  Board Certified physicians or equivalent
  Exclusion Criteria:
  -  Did not participate in EOS Protocols 20061 or 20081

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Safety Study of a Liposomal Vaccine to Treat Malignant Melanoma

Summary: The purpose of this study is to determine whether Lipovaxin-MM, a new anti-cancer vaccine, is safe and effective in improving the body's ability to destroy cancer cells in patients with metastatic melanoma.


Eligibility: Key Inclusion Criteria:
  -  Patients with incurable stage IV malignant melanoma for which no standard or curative therapy exist OR patients locoregionally recurrent melanoma (including local metastases, in transit metastases and satellitosis) where surgery is not the best therapeutic option.
  -  Must be able and willing to provide written informed consent.
  -  Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  -  Life expectancy of ≥12 weeks.
  -  Female subjects must be of non-child-bearing potential or using appropriate contraception.
  -  Positive test for cell mediated immunity.
  Key Exclusion Criteria:
  -  Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry and stable without steroid treatment for at least 4 weeks.
  -  Previous immunotherapy (except IL-2 or interferon-based therapy) for melanoma.
  -  Inadequate bone marrow reserve.
  -  Serum bilirubin ≥1.2 times the upper limit of normal.
  -  In absence of metastases, liver transaminase levels greater than 1.5 times the upper limit of normal.
  -  If metastases are evident, liver transaminase levels 2.5 times the upper limit of normal will be acceptable.
  -  Inadequate renal function.
  -  Evidence of severe or uncontrolled systemic diseases.
  -  Unresolved toxicity ≥CTC Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
  -  Participation in a trial of an investigational agent within the prior 30 days.
  -  HIV infection.
  -  Immunosuppressive therapy including corticosteroids within 4 weeks of screening.
  -  Pregnant or breast-feeding females.

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

Summary: This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


Eligibility: Inclusion Criteria:
  -  cutaneous malignant melanoma;
  -  advanced, inoperable stage IV melanoma;
  -  measurable and/or evaluable sites of metastases.
  Exclusion Criteria:
  -  prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;
  -  prior malignancies within past 5 years, with the exception of cured non-melanoma skin cancer, or in situ cancer of cervix;
  -  clinically significant cardiovascular disease;
  -  ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

Summary: Phase I study of SPARC1023 alone and in combination with carboplatin

Detailed description: Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.

Eligibility: Inclusion Criteria:
  -  Age ≥18 years
  -  ECOG Performance Status ≤ 1.
  -  Estimated life expectancy of at least 12-weeks;
  -  Measurable disease as per RECIST guideline (Version 1.1);
  Exclusion Criteria:
  -  Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
  -  Known hypersensitivity to the study drugs
  -  Treatment with any anti-cancer agents within 28 days of study entry
  -  Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: A Study of RO5185426 in Patients With Metastatic Melanoma

Summary: This open-label, multicenter study will evaluate the safety and efficacy of RO5185426 in patients with BRAF V600 mutation-positive, surgically incurable and unresectable stage IIIC or IV metastatic melanoma. Eligible patients will receive RO5185426 (960 mg twice daily orally) until disease progression or unacceptable toxicity occurs, with a safety follow-up of 24 months after discontinuation of the study drug.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 16 years of age
  -  Histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
  -  Patients may or may not have received prior systemic therapy for metastatic melanoma
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  -  Adequate hematologic, renal and liver function
  Exclusion Criteria:
  -  Evidence of symptomatic CNS lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of RO5185426
  -  Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
  -  Concurrent administration of any anti-cancer therapies other than those administered in the study
  -  Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
  -  Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption

Relevance to patient case: not relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

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: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma

Summary: The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations.


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery
  -  BRAF or NRAS mutation in tumor tissue
  -  All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol
  -  Evidence of measurable tumor disease as per RECIST
  -  WHO performance status of 0-2
  -  Adequate organ function and laboratory parameters
  Exclusion Criteria:
  -  History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or any eye condition that would be considered a risk factor for CSR or RVO
  -  Patients with unstable CNS metastasis
  -  Prior treatment with a MEK- inhibitor
  -  Impaired cardiovascular function
  -  HIV, active Hepatitis B, and/or active Hepatitis C infection
  -  Pregnant or nursing (lactating) women
  -  Women of child-bearing potential UNLESS they comply with protocol contraceptive requirements
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: possibly relevant
Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

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: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

Summary: Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.

Detailed description: Technique development: In first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without GNAQ mutation.
  Validation: The tumor DNA detection rate will be estimated from metastatic uveal patient's blood. The investigators will study 40 patients to obtain at least 15 patients bearing a GNAQ mutation in the primitive tumor or in metastasis. With those 15 patients, the investigators will determinate the most sensitive technique and the best cost/efficiency ratio.

Eligibility: Inclusion Criteria:
  -  Age > or = 18 years.
  -  Patient with a metastatic choroidal melanoma.
  -  Patient with tumor or metastasis available for GNAQ (Guanine nucleotide blinding protein) status characterization.
  -  Patient able to stand a blood collection.
  -  Signed written informed consent approved by competent authority and ethic committee.
  Exclusion Criteria:
  -  Patient without social protection/insurance.
  -  Current pregnancy and lactation.
  -  All social, medical, psychological, situations making the study impossible.
  -  Person deprived of liberty.

Relevance to patient case: not relevant