araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer

Summary: MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles.
  During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations.
  Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.

Detailed description: During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed.
  During the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis:
  Non-small cell lung cancer with genetic alterations in MET, AXL, RET, TRK, DDR2, KDR, PDGFRA, KIT or CBL.
  Head and neck squamous cell carcinoma with genetic alterations in MET.
  Clear cell renal cell carcinoma refractory to angiogenesis inhibitors.
  Metastatic prostate cancer with bone metastases.
  Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs.

Eligibility: Inclusion Criteria:
  -  Metastatic or unresectable solid tumor malignancy
  -  Standard treatment is not available
  -  Adequate bone marrow and organ function
  Exclusion Criteria:
  -  History of a significant cardiovascular illness
  -  Prolonged corrected QT (QTc) interval
  -  Left ventricular ejection fraction < 40%
  -  Symptomatic or uncontrolled brain metastases
  -  Other active cancer

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Use of Exome Sequence Analysis and Circulating Tumour in Assessing Tumour Heterogeneity in BRAF Mutant Melanoma

Summary: Despite recent advances in cancer treatment, little impact has been made on curing as opposed to controlling cancers over the last several decades. Part of the problem is that investigators have an incomplete understanding of how tumours behave as they evolve and in response to treatment. In this trial, the investigators hope to better understand the evolution of BRAF melanoma in response to drugs a patient may have received such as vemurafenib or dabrafenib. Importantly, the investigators want to understand how the tumours evolve resistance to these drugs and whether this can be predicted through blood tests, in particular of the circulating tumour DNA.

Detailed description: Study population: BRAF mutant melanoma patients
  Pre-mortem bloods will be taken from the patient on three occasions at one to thirty days apart from each other, with the first blood draw taking place on the patient's first clinic visit. Six 7 ml EDTA and one 6 ml SST vacutainers of blood (a total of approx. 50 ml of blood) will be taken from the patient.
  When death is expected within the next 48-72 hours, the Medical Oncologist/ Radiation Oncologist/ Hematologist OR delegate will revisit the RAP process with the patient and/or family/substitute decision maker to ensure that they are still in agreement. The patient and the families will also be provided with an additional consent form for participation including blood sampling.

Eligibility: Inclusion Criteria:
  UHN adult patient with BRAF mutant melanoma
  Exclusion Criteria:
  Non BRAF mutant melanoma patient Pediatric patient Non-UHN patient

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer

Summary: To investigate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162


Eligibility: Inclusion Criteria:
  -  Advanced (stage IIIB or stage IV) NSCLC
  -  Must have specific molecular alterations
  Exclusion Criteria:
  -  Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 4 weeks prior to study entry to control their CNS disease
  -  Radiation therapy within ≤ 4 weeks prior to study entry, with the exception of limited field palliative radiotherapy for bone pain relief.
  -  Any other malignancies within the last 5 years before study entry
  -  Major surgery ≤ 2 weeks prior to study entry or who have not recovered from side effects of such therapy
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Pancreatic Cancer Screening of High-Risk Individuals in Arkansas

Summary: 100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.


Eligibility: Inclusion Criteria:
  -  Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome - STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis - PRSS1
  -  Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree)
  -  Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening.
  -  Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC.
  -  Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening.
  -  Patients with a known BRCA1 or BRCA2 mutation with one affected 1st or 2nd degree relative should be considered for screening.
  -  Patients with a known PALB2 mutation with one affected family member should be considered for screening.
  -  Patients with a known Mismatch-repair gene-mutation carriers (Lynch syndrome) with one affected family member should be considered for screening.
  Exclusion Criteria:
  -  Not candidates for surgery

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Automatic Early Melanoma Detection by Ultrahigh Resolution Three Dimensional Optical Coherence Tomography

Summary: The investigators will use optical coherence tomography to detect the ex-vivo tissue image of surgical removed melanoma or other benign pigmented lesions of skin.

Detailed description: The investigators will use an advanced high resolution 3D optical coherence tomography (OCT) technology to observe skin tissue images in ex vivo culture. Parts of melanoma or benign pigmented lesions specimens derived from biopsy or surgical excision specimen will be observed by 3D optical tomography. A tiny tissue fragment of melanoma or benign pigmented lesions will be taken from surgical specimen without interference normal pathological evaluation. The location of melanocytic cells in melanoma or benign tissue fragments will be mapped by the 3D optical coherence tomography (OCT). The 3D optic tomography system utilize a Ce:YAG optical fiber as light source and also combined with confocal microscopy. Taken together, these features made the 3D optic tomography system have very high resolution and suitable for single cell imaging. This study will not interfere with the normal medical practice and had no impact on patient's safety and health. All of the materials will be destroyed once the experiments are done. The enrollment criteria will be dermatological patients who need to surgical intervention.

Eligibility: Inclusion Criteria:
  -  Patients aged older than 20 years old
  -  Patients who had melanoma, melanoma in situ, and/or other benign pigmented lesions,
  -  Patients who had non-melanoma skin cancers (basal cell carcinoma, or squamous cell carcinoma).
  -  Patients who had precancerous skin lesions (Bowen's disease, actinicc keratosis)
  Exclusion Criteria:
  • Pregnant women.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Quality of Life and Surgical Late Effects of Melanoma Treatment

Summary: Health-related Quality of life in Danish stage IB-III cutaneous melanoma patients.

Detailed description: The aim of the PhD-study is to evaluate, in a large cohort of Danish melanoma patients:
  1. Health-related quality of life assessing psychological, physical and social well-being
  2. Physical long term side effects (lymphoedema, scarring and neuropathic pain)
  3. Lymphoedema assessed by clinical examination and DXA scans

Eligibility: Inclusion Criteria:
  -  AJCC stage IB-III cutaneous melanoma patients
  -  At least one year follow-up after melanoma surgery
  Exclusion Criteria:
  -  Pregnancy
  -  Bilateral axilla or groin melanoma surgery

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: 5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results

Summary: The INTEGRATE Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed. Data will be collected through review of medical records from clinical visits with physician.
  The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.


Eligibility: Inclusion Criteria:
  -  Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
  -  Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
  -  16 Years and older
  Exclusion Criteria:
  -  Less than 16 Years of age

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes

Summary: The EXPAND Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data will be collected through review of medical records from clinical visits with physician.
  The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.


Eligibility: Inclusion Criteria:
  -  Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
  -  Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
  -  16 Years and older
  Exclusion Criteria:
  -  Less than 16 Years of age

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Patients With Refractory, Metastatic Cancer Harboring KIT Mutation or Amplification to Investigate the Clinical Efficacy and Safety of Imatinib Therapy

Summary: KIT is a receptor tyrosine kinase that binds to stem-cell factor (SCF), activating a series of downstream effector pathways. KIT is an established therapeutic target in cancer with activating mutations of KIT, such as gastrointestinal stromal tumors (GIST), and significant benefit is achieved with various small molecule inhibitors of KIT such as imatinib mesylate. Moreover, there is increasing evidence implicating KIT mutations as tractable therapeutic targets in melanoma. Additional information is required to characterize the functional role of low-frequency mutations in KIT and to determine whether amplification of wild type KIT is a real driver that can be targeted therapeutically. Except GIST and melanoma, other solid cancers were reported to have KIT mutation even in low frequency. A molecular profiling of the tumors of patients referred to the phase I clinic at the M.D. Anderson Cancer Center showed KIT mutation in 7 patients in total of 431 patients (2%).
  Hence, the investigators planned this study to apply the molecularly targeted agent, imatinib to various types of cancers harboring KIT mutation or amplification.


Eligibility: Inclusion Criteria:
  1. age ≥ 20
  2. advanced, refractory cancer patients who failed standard of care (SOC)
  3. KIT aberration: defined as mutation in exons 9, 11, 13, 17 or 18, or nanostring CNV by quantitative PCR (greater than 3 copies) or subject with specific sensitivity (Z-score<-1) to imatinib by Avatar scan whose disease has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy
  4. ECOG performance status of 0~2
  5. measurable or evaluable lesion per RECIST 1.1 criteria
  6. adequate marrow, hepatic, renal and cardiac functions
  -  Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
  -  Total serum bilirubin ≤ 1.5 x ULN
  -  Absolute neutrophil count(ANC) ≥ 1,500/uL
  -  Platelets ≥ 100,0000/uL
  -  Hemoglobin ≥ 9.0 g/dL
  7. provision of a signed written informed consent
  Exclusion Criteria:
  1. severe co-morbid illness and/or active infections
  2. pregnant or lactating women
  3. history of major surgery or radiotherapy within 4 weeks
  4. active CNS metastases not controllable with radiotherapy or corticosteroids (however, CNS metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
  5. known history of hypersensitivity to study drugs

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

Summary: The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis).


Eligibility: Inclusion Criteria:
  -  The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease
  -  The patient with progressive CRF
  Exclusion Criteria:
  -  The patient with secondary glomerular disease
  -  The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Videoscopic Ilioinguinal Lymphadenectomy for Melanoma

Summary: Groin lymph node dissection for melanoma patients is burdened by high post-operative morbidity, mainly related to wound. This is a prospective pilot trial investigated feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in patients with inguinal lymph node melanoma metastases.

Detailed description: Videoscopic ilioinguinal dissection is a two-stage procedure. Dissection is performed using an ultrasound dissector. The inguinal step is performed via three ports (one 3-5 cm above the apex of the femoral triangle, a second 5 cm medial to the adductors, and the third 5 cm lateral to the Sartorius muscle). After subcutaneous inflation, a formal inguinal lymph node (LN) dissection is performed, removing the contents of the femoral triangle, with incision and removal of the femoral fascia and proximal and distal ligation of the saphenous vein with vascular endostaplers and endoclips. The specimen is extracted using an endobag from the incision of SLNB, which is systematically removed, or through a small enlargement of the incision of the apex trocar for patients with clinically positive LNs. The iliac step starts with open insertion in the pro-peritoneal space of a Hasson trocar, followed by positioning of two additional trocars (5 and 10 mm respectively) just laterally of the umbilical pubic line. After creation of pneumo-pelvis, the iliac femoral vessels are identified, isolated and all the external iliac LNs removed. Afterwards, the obturator LNs are dissected off the obturator nerve. LNs are retrieved with an endobag or directly through the 10mm trocar after insertion of protective endotrocar. Two drains are positioned at the end of procedure in the obturator fossa and in the inguinal space, respectively. Intra-operative and early post-operative outcome (lenght of stay, complications, number of LNs) is recorded. Follow-up consists in detection of any recurrence, measurement of lymphedema of the leg and evaluation of quality of life

Eligibility: Inclusion Criteria:
  Melanoma patients without distant metastasis and either positive SLNB or clinically positive inguinal lymph nodes
  Exclusion Criteria:
  American Society of Anaesthesiologists (ASA) classification III-IV Severe chronic obstructive pulmonary disease (COPD) and other restrictive lung disease, Severe ischemic heart disease and chronic heart failure Previous cerebral abnormalities (aneurysm/arteriovenous malformations, ischemic/hemorrhagic stroke, primary or secondary tumors), History of deep vein thrombosis (DVT) Childbearing state Severe hip functional limitation Previous hip/knee arthroplasty. Previous surgery in the groin region (e.g., hernia repair, great saphenous vein surgery, iliac-femoral bypass) was considered a contraindication only for the iliac stage of lymphadenectomy.

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: A Study Comparing Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping

Summary: Open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of Lymphoseek and compared with VBD in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from neonatal through 17 years.


Eligibility: Inclusion Criteria:
  -  The subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the subject also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted
  -  Subject has been diagnosed with melanoma, rhabdomyosarcoma, or other tumor where tumor resection or biopsy is planned and lymph node mapping is appropriate
  -  The subject is clinically node negative (cN0) at the time of screening
  -  Age < 18 years
  -  Male subjects of childbearing potential must be willing to use a condom during sexual intercourse and shall not father a child during the course of the study or will practice complete abstinence while on study
  -  Female subjects of childbearing potential must agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study
  Exclusion Criteria:
  -  The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy
  -  Has had previous surgery or radiation to node basins that would be involved in the intraoperative lymph node mapping (ILM) procedure
  -  Has a known allergy to VBD or dextran
  -  Has a history of alcohol abuse or alcohol dependency in the 3 years before study entry, or is an alcoholic or drug addict, as determined by the investigator
  -  Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
  -  Is scheduled for additional surgery other than the primary surgical intervention within the 7 days after Lymphoseek administration
  -  Has rhabdomyosarcoma of the intrathorasic region

Relevance to patient case: not relevant
Patient case: 60-year-old male with melanoma; genetic feature: NTRK1 rearrangement

Clinical trial: Application of Genomic Techniques and Image Processing Using Artificial Intelligence to Obtain a Predictor Model Risk of Melanoma

Summary: The aim of this study is to develop a predictive model of risk of developing melanoma. The investigators will used artificial intelligence techniques to analysed images patterns obtained by clinical and dermoscopic pictures. The investigators want to defined a new predictive risk model obtained from genetic information and image analysis of pigmented lesions. This model could help to discriminate more accurately those patients who are most likely to develop melanoma in a high-risk population.


Eligibility: Inclusion Criteria:
  -  ≥18 years of age;
  -  Followed up patients in the Pigmented Lesions Unit at Reina Sofia University Hospital with high risk of developing melanoma (First-degree family/personal history of familiar melanoma and/or melanocyticnevi above 50 and/or dysplastic or atypical nevi);
  -  All nevi for which there is at least one dermatoscopy registry will be included.
  Exclusion Criteria:
  -  not enough data in the patient clinical history;
  -  located lesions on the face, scalp, mucous membrane or on acral área;
  -  nodular or metastatic melanoma diagnosis
  -  type V or VI of Fitzpatrick phototyping scale

Relevance to patient case: not relevant