araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Clinical and Histological Features of Head and Neck Melanoma

Summary: The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.

Detailed description: Aim of the study was to compare clinical and histological characteristics between head and neck melanomas and melanomas at other sites.

Eligibility: Inclusion Criteria:
  -  patients with melanoma
  -  melanoma diagnosed between January 2004 and December 2011
  -  patients living in Champagne-Ardenne

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo

Summary: The purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.


Eligibility: Inclusion Criteria:
  -  Subjects currently working at the Local Health Authority of the province of Bergamo
  Exclusion Criteria:
  -  Subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis

Summary: Characterisation of effect of SIRT and DSM-TACE as local treatment options for liver metastases in patients with advanced uveal melanoma with respect to progression-free survival and exploratory comparison of secondary endpoints regarding application, activity, adverse effects and impact on quality of life in a randomized study design.

Detailed description: This is a randomized phase II trial to evaluate the effect of transarterial radioembolisation with yttrium-90 microspheres (SIRT) and transarterial chemoembolisation with cisplatin (DSM-TACE) in patients with liver metastases due to advanced uveal melanoma in terms of progression-free survival and multiple secondary endpoints.
  Patients in study arm A will receive transarterial radioembolisation one time only. Patients in study arm B will receive transarterial chemoembolisation every 4 to 6 weeks until complete tumor devascularisation is observed or disease progression or intolerable toxicity occur. At the time of local tumor progression patients will be offered the other treatment respectively (either SIRT or DSM-TACE) as part of the study.

Eligibility: Inclusion Criteria (main):
  -  ECOG Performance Status of 0, 1 or 2
  -  Histologically or cytologically confirmed liver metastases of uveal melanoma
  -  At least one measurable lesion according to RECIST criteria v1.1 determined MRI (if contraindications against MRI exist CT with contrast media can is allowed)
  -  Metastases in other sides are allowed if not in need of treatment (e.g. asymptomatic bone metastasis without indication for radiation)
  -  Prior treatment with systemic anti-cancer therapy is allowed if terminated ≥ 4 weeks prior to study treatment start and recovery from toxicity is achieved
  -  Surgery in general and hepatic surgery in particular (e.g. lobe resection, radiofrequency ablation) prior to study enrollment are allowed if realized ≥ 4 weeks prior to study enrollment and recovery from surgery is achieved
  Exclusion Criteria (main):
  -  Surgically treatable liver metastases
  -  Previous intraarterial hepatic treatment (e.g. radioembolisation, chemoembolisation, intraarterial chemotherapy, isolated or percutaneous hepatic perfusion)
  -  Previous treatment with external liver radiation
  -  Major intrahepatic occlusion of the portal vein and/or tumor infiltration of the portal vein
  -  Liver cirrhosis Child-Pugh C
  -  Progressive liver failure
  -  Renale failure, bone marrow insufficiency, coagulopathy
  -  Uncontrolled or severe medical conditions which could impair the ability to participate in the trial such as unstable cardiac disease or uncontrolled infection
  -  Other malignancy and/or metastases in need of treatment
  -  Current treatment with any anti-cancer therapy

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.

Summary: To characterize the safety and tolerability of NIS793 as single agent and in combination with PDR001 and to identify recommended doses for future studies.


Eligibility: Inclusion Criteria:
  1. Written informed consent must be obtained prior to any screening procedures.
  2. Patient (male or female) ≥ 18 years of age.
  3. Escalation: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
  4. Expansion: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have progressed despite standard therapy following their last prior therapy or are intolerant to standard therapy and fit into one of the following groups: Group 1: NSCLC; Group 2: TNBC; Group 3: HCC; Group 4: MSS-CRC; Group 5: pancreatic, prostate and ccRCC.
  5. ECOG Performance Status ≤ 2.
  6. Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on this study. Exceptions may be made on a case by case basis after documented discussion with Novartis.
  Exclusion Criteria:
  1. History of severe hypersensitivity reactions to study treatment ingredients or other monoclonal antibodies and components of study drug.
  2. Patients with active, known or suspected autoimmune disease. Note: Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  3. HIV infection.
  4. Active HBV or HCV infection.
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: possibly relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Screening Study for Cervical Pre-cancer and Cancer Prevention in South African Women.

Summary: Nearly 8 000 new cervical cancer cases are diagnosed in South Africa per year; many are still undiagnosed and about 50% of diagnosed cases succumb per year. Although the current prevalence of pre-cancer cervical disease is largely unknown, data from local studies suggest regional differences and an increase in the prevalence of cytological abnormalities when compared with historical data. Low frequency in cytology screening is the primary factor attributable to development of invasive cervical cancer and almost one-third of all cervical cancer patients had previous negative cytology. Due to the low sensitivity of cytology it can be assumed that the true prevalence of pre-cancer disease is underestimated by all available data. One round of optimal cervical cytology will detect around 50% of existing pre-cancer cervical disease as identified and proven using colposcopy and directed biopsy. It is now widely accepted that primary screening with a human papilloma virus (HPV) test can improve the sensitivity of screening and that even a single round of HPV screening can rapidly reduce the incidence of invasive cervical cancer and related mortality within a few years.
  South Africa has a high prevalence of HIV infection and a delay in or failure to initiate antiretroviral therapy (ART). These facts, together with the largely unscreened status of the female population and the high incidence of cervical cancer all suggest that HPV infection and precursors to cervical cancer are both unusually common among South African women. Accurate current knowledge of the performance of newer generation HPV based screening tests in HIV-infected and general female population are essential for cost-analysis and planning for national prevention and screening programs. This study will aim to demonstrate the feasibility and efficacy of new generation HPV deoxyribonucleic acid (DNA) based screening assays in a South African setting.
  The investigators hypothesize that HPV testing followed by normal and special cytology tests will be a successful screening model for a South African population.


Eligibility: Inclusion Criteria:
  -  Informed consent accepted and signed
  -  Health seeking behaviour or request for a cervical cancer screening test
  -  Willing and able to receive test result by automated text message or clinic visit
  Exclusion Criteria:
  -  Current pregnancy
  -  Hysterectomy
  -  Current or previous treatment for gynaecological cancer
  -  Hesitant or unable to undergo screening and treatment if indicated

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Summary: To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma


Eligibility: Inclusion criteria Part 1: Safety run-in
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
  -  ECOG performance status ≤ 1
  Part 2: Biomarker cohort
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
  -  ECOG performance status ≤ 2
  Part 3: Double-blind, randomized, placebo-controlled part
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  Part 1: Safety run-in
  -  Subjects with uveal or mucosal melanoma
  -  Any history of CNS metastases
  -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
  -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
  -  Radiation therapy within 4 weeks prior to start of study treatment
  -  Active, known, suspected or a documented history of autoimmune disease
  Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
  -  Subjects with uveal or mucosal melanoma
  -  Clinically active cerebral melanoma metastasis
  -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
  -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
  -  Radiation therapy within 4 weeks prior to start of study treatment
  -  Active, known, suspected or a documented history of autoimmune disease
  Other protocol-defined Inclusion/Exclusion may apply.

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma

Summary: The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic KIT-mutated melanoma.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Unresectable stage III or stage IV melanoma which is histologically confirmed at the treating institution with KIT mutation(s) not known to be resistant to PLX3397
  -  Presence of measurable lesions by Response Evaluation Criteria in Solid Tumors
  -  Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-2
  -  Life expectancy ≥ 3 months
  -  Adequate organ and bone marrow function
  -  Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drug. Women of non-child-bearing potential must have been postmenopausal for ≥ 1 year or surgically sterile.
  -  Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug.
  -  Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements
  Exclusion Criteria:
  -  Prior treatment with a KIT inhibitor for melanoma
  -  Presence of NRAS or BRAF mutation
  -  Exposure to any investigational drug within 28 days or unresolved adverse effects from previous therapy
  -  Symptomatic brain metastases.
  -  Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Sponsor
  -  Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable)
  -  Uncontrolled intercurrent or infectious illness
  -  Major surgical procedure or significant traumatic injury within 14 days of initiating study drug or anticipation of the need for major surgery during the study
  -  Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 28 days prior to study entry
  -  Inability to swallow capsules, or refractory nausea and vomiting, malabsorption, an external biliary shunt, or significant bowel resection that would preclude adequate absorption
  -  Congestive heart failure (CHF) New York (NY) Heart Association class III or IV; unstable coronary artery disease (myocardial infarction [MI] more than 6 months prior to study entry is permitted); or serious cardiac arrhythmia
  -  Baseline QTcF ≥ 450 msec (for males) or ≥ 470 msec (for females) at Screening
  -  Active or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
  -  Known chronic liver disease
  -  Women who are breast-feeding or pregnant

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Real-Life Efficacy and Safety of Nivolumab Monotherapy or in Combination With Ipilimumab in Patients With Advanced (Unresectable or Metastatic) Melanoma

Summary: Real-Life Efficacy and Safety of Nivolumab monotherapy or in combination with Ipilimumab in Patients with Advanced (Unresectable or Metastatic) Melanoma


Eligibility: Inclusion Criteria:
  -  ≥ 18 years
  -  advanced melanoma (Stage III/Stage IV)
  -  histologically confirmed diagnosis
  -  treatment decision for nivolumab mono- or combination therapy already taken
  -  signed informed consent
  Exclusion Criteria:
  -  current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment
  -  previous treatment with nivolumab
  -  current active participation in an interventional clinical trial for treatment of advanced melanoma

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma

Summary: This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.

Detailed description: After randomization, participants will undergo surgery with wide local excision with either 1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure considerations may require removal of additional tissue for non-oncologic purposes. As per standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique (technetium radiolabeled sulfur colloid and isosulfan blue) with or without lymphoscintigraphy.

Eligibility: Inclusion Criteria:
  -  Biopsy proven T2 malignant melanoma.
  -  Eastern Cooperative Oncology Group (ECOG) score of 0-2.
  Exclusion Criteria:
  -  Visible additional disease that suggests a greater than T2 malignant melanoma
  -  Unable to tolerate general anesthesia
  -  Evidence of distant metastatic disease
  -  Melanoma located on face or digits

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Phase 1B Study in Subjects With Small to Medium Primary Choroidal Melanoma

Summary: The primary objective is to assess the safety, immunogenicity and preliminary efficacy of a single treatment of one of two dose levels of Light-activated AU-011 for the treatment of subjects with primary choroidal melanoma.

Detailed description: This is a phase 1B open-label, single ascending dose clinical trial designed to evaluate the safety of two dose levels of Light-activated AU-011 for the treatment of subjects with small to medium primary choroidal melanoma.
  Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.

Eligibility: Inclusion Criteria:
  -  Diagnosis of uveal melanoma
  Exclusion Criteria:
  -  Have known contraindications or sensitivities to the study drug

Relevance to patient case: not relevant
Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Risk Stratification Among Individuals Who Have Many Moles on Their Skin

Summary: The investigators are doing this study to improve our ability to identify which people with many moles on their skin are most likely to develop skin melanoma. The investigators hope to identify features of moles that are associated with melanoma risk. The investigators hope to use this information to customize and tailor melanoma screening to the individual patient based on a better estimate of their individual risk.


Eligibility: Inclusion Criteria:
  -  Patients ≥ 18 years of age
  -  High-risk nevus phenotype (≥ 50 nevi and ≥ 1 atypical nevus)
  -  First presented to MSKCC for cutaneous melanoma-related care within the past 12 months
  -  Cases: recent diagnosis (≤ 12 months) of unequivocal invasive cutaneous melanomas (AJCC Stages I-IV) confirmed by MSKCC pathology
  -  Cases: completion of surgical treatment of primary melanoma
  -  Ability to sign informed consent
  Exclusion Criteria:
  -  Known germline high-penetrance melanoma predisposition mutation (that is, CDKN2A and CDK4)
  -  Cases: history of invasive cutaneous melanoma (AJCC Stages I-IV) not confirmed by MSKCC pathology, history of acrolentiginous type of cutaneous melanoma
  -  Cases: history of systemic adjuvant therapy or treatment of metastatic melanoma, including: MEK inhibitors (trametinib, cobimetinib, etc.), BRAF inhibitors (vemurafenib, dabrafenib, etc.), and immunotherapy (pembrolizumab, nivolumab, atezolizumab, ipilimumab, etc.). Controls: history of Stage 0-IV melanoma confirmed by MSKCC pathology
  -  History of limb amputation or other condition (e.g., tattoos, burns) per investigator discretion that would modify nevus phenotype
  -  Physical inability to undergo total body photography or reflectance confocal microscopy imaging (that is, remain relatively still for durations of 3-5 minutes)
  -  Known hypersensitivity to adhesive rings used for reflectance confocal microscopy
  -  Inability to give informed consent
  -  Have skin afflicted with anther skin condition (for example, psoriasis) that would affect ability to characterize nevus phenotype (per investigator discretion)
  -  Familial cutaneous melanoma history (families with at least one invasive melanoma and two or more other diagnoses of invasive melanoma or pancreatic cancer among first- or second-degree relatives on the same side of the family). We will confirm melanoma family history via medical record documentation, whenever possible, as recommended by previous studies that disproved about half of the reported family histories of melanoma among first-degree relatives in case-control studies.

Relevance to patient case: not relevant