araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors

Summary: This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2 Amplification Refractory solid tumors.
  This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression.
  To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. RET fusion positive,FGFR amplification, Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. Any previous treatment with sunitinib

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Study of Apatinib in RET Fusion Positive Advanced Non-small Cell Lung Cancer

Summary: RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.

Detailed description: To observe objective response rate (ORR) of apatinib in RET fusion positive pre-treated advanced NSCLC.
  To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess safety and tolerability. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of apatinib.

Eligibility: Inclusion Criteria:
  -  Aged ≥18 and ≤80 years.
  -  ECOG performance status of 0 to 1.
  -  Life expectancy of more than 12 weeks.
  -  At least one measurable lesion exists.(RECIST 1.1)
  -  Histologically or cytologic confirmed RET fusion positive advanced Non-small cell lung cancer who failed to prior therapies.
  -  Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms
  -  Signed informed consent
  -  Females of child-bearing potential must have negative serum pregnancy test. Sexually active male and those having childbearing potential must practice contraception during the study.
  Exclusion Criteria:
  -  Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer
  -  Subjects with third space fluid that can not be controled by drainage or other methods.
  -  Obvious cavity or necrosis formed in the tumor
  -  Uncontrolled hypertension
  -  Hymoptysis, more than 2.5ml daily
  -  Thrombosis in 12 months, including pulmonary thrombosis, stroke, or deep venous thrombosis
  -  Received big surgery, had bone fracture or ulcer in 4 weeks
  -  Urine protein >++, or urine protein in 24 hours> 1.0g
  -  pregnant or lactating woman
  -  Receiving any other antitumor therapy.
  -  Known history of hypersensitivity to apatinib or any of it components.

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Study of Anlotinib in Patients With Medullary Thyroid Carcinoma(ALTER01031)

Summary: To compare the effects and safety of Anlotinib with placebo in patients with Medullary Thyroid Carcinoma.


Eligibility: Inclusion Criteria:
  1. Signed and dated informed consent
  2. Histological documentation of medullary thyroid carcinoma(MTC),Unable to surgery(Stage IV) or metastasis ,With measurable disease (using RECIST1.1)
  3. ECOG PS:0-1,Life expectancy of more than 6 months
  4. main organs function is normal
  Exclusion Criteria:
  1. Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)
  2. Subjects received radiotherapy external exposure within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study
  3. Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) ]
  4. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin
  5. Patients with factors that could affect oral medication (such as dysphagia etc.)
  6. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life])
  7. Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors

Summary: This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive, FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  To investigate the efficacy and safety of Sunitinib in patient with Refractory solid tumor.


Eligibility: Inclusion Criteria:
  -  Provision of fully informed consent prior to study specific procedures.
  -  Patients must be >= 19 years of age
  -  RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  ECOG Performance status0-2
  -  Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
  -  Adequate Organ Function Laboratory values
  -  Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL
  -  Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  -  Adequate heart function
  Exclusion Criteria:
  -  Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
  -  Has known active central nervous system(CNS) metastases
  -  Has an active infection requiring systemic therapy
  -  Pregnancy or breast feeding
  -  Patients with cardiac problem
  -  Any previous treatment with sunitinib

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

Summary: Primary Objective:
  To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM).
  Secondary Objectives:
  -  To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
  -  To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM.
  -  To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.

Detailed description: The total study duration per patient will be approximately 6 to 13 weeks that will consist of a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and 1-day end of study visit.

Eligibility: Inclusion criteria :
  -  Japanese male or female patients with T2DM diagnosed for at least 1 year prior to the time of screening as established in the medical history.
  -  Patients aged 20 to 75 years at screening.
  -  Body mass index ≤35 kg/m^2 at screening.
  -  Glycohemoglobin ≥7.0% and ≤10.0% at screening.
  -  Fasting C-peptide ≥0.6 ng/mL at screening.
  Exclusion criteria:
  -  Diabetes other than T2DM.
  -  History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
  -  History of hypoglycemia unawareness.
  -  Hemoglobinopathy or hemolytic anemia.
  -  History of myocardial infarction, stroke, or heart failure, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period.
  -  History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.
  -  Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment.
  -  Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).
  -  If female, pregnancy or breast-feeding.
  The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Clinical Equivalency Validation Protocol Clinical Equivalency Eyenez Retina Camera v200 and Optomed Smartscope M5 EY3

Summary: This prospective equivalency study compares the performance of two Ophthalmic Cameras, the Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained technicians will take pictures of the same patients' retinas and the quality of the photos will be evaluated. The study includes healthy patients and patients with a spectrum of retinal diseases. The study requires that technicians take pictures of the retinas of adult patients between 18 and 80 years of age using both the OC and OP. The pictures will be reviewed and compared by a central reader/Ophthalmologist, who will determine if the OC is equivalent to the OP, based on the quality of the images

Detailed description: Subjects (patients) will be recruited via word of mouth.
  The study duration will be approximately 1-2 weeks, assuming a recruitment rate of 15 subjects per week. The images will be recorded within 15 minutes and will involve minimal disruption to the clinical workflow.
  In the Study Environment setting (Foothill Medical Offices), the User Interface will be evaluated by comparing retinal pictures taken with subject device OC and predicate device OP.
  Patient subjects will be given an Information and Consent Form to complete prior to the study
  The technicians employed by Foothill Eye Clinic will operate the device on patient participants by taking a retinal picture using OC.
  The technicians will use the predicate device OP to take retinal pictures.
  The Ophthalmologist will compare the results with the pictures taken by OC and OP. The Ophthalmologist will be blinded to what picture was taken by which camera and record his assessment of the quality for each picture.
  Patient subjects will receive a standard of care exam with or without dilation.

Eligibility: Healthy subjects Inclusion Criteria:
  -  Written Informed Consent
  -  Male or female
  -  Age ≥ 18 years and ≤80 years
  -  Normal Retina
  Healthy subjects Exclusion Criteria:
  -  Glaucoma
  -  Limited Ability for Agreement
  -  Spectrum of retinal diseases
  -  Subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit
  Diseased subjects Inclusion Criteria:
  -  Written Informed Consent
  -  Male or female
  -  Age ≥ 18 years and ≤80 years
  -  Spectrum of retinal diseases
  Diseased subjects Exclusion Criteria:
  -  Normal Retina
  -  Limited Ability for Agreement
  -  Subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: A Phase I, Randomized, Placebo-controlled, Double Blind, Repeat Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106 in Normal Subjects

Summary: The current study is designed to assess the safety, tolerability, pharmacokinetics (PK), gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized, double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.


Eligibility: Inclusion Criteria:
  -  Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
  -  Healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. History of regular bowel habits
  -  Male or Female of non-childbearing potential.
  -  Capable of giving signed informed consent which includes compliance with the requirements and restrictions
  Exclusion Criteria:
  -  ALT and bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1. ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  -  Estimated Glomerular Filtration Rate <60 milliliter per minute per 1.73 square meter (mL/min/1.73m^2)
  -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  -  History of Gastroesophageal reflux disease (GERD), dyspepsia, GI bleeding, GI surgery that could affect motility

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin

Summary: The aim of the trial is to study a radiating diagnosis agent used in post surgery when the biological assessment highlighted a residual disease.
  This is an inter-regional multicentric, prospective study evaluating the benefit of PET F-DOPA imaging in involved node detection compared to standard imaging assessment in patient with medullary thyroid cancer.
  The purpose of the study is to evaluate the impact and performance of a new PET / CT (computerized tomography ) tracer targeting dopamine receptor in patient with residual ganglionar biological disease after initial surgery of medullary thyroid cancer compared to standard imaging.
  Obtained data will be compared to the "gold standard" based on :
  -  nodes cytology when they could be punctured
  -  histology when a new surgery will be recommended
  -  surveillance when the 2 first cases will be not applicable (imaging monitoring, evolution of thyrocalcitonin)


Eligibility: Inclusion Criteria:
  1. Age > or = 18 years.
  2. Patient with medullary thyroid cancer (sporadic or hereditary form).
  3. Patient treated by total thyroidectomy with uni or bi-lateral lymph node dissection (in the central and/or lateral neck compartment).
  4. Patient with elevated thyrocalcitonin rate > or = 150 pg/ml assessed within 6 weeks or more after surgery.
  5. Patient with standard imaging assessment performed during 3 months before PET 18-FDOPA.
  6. Standard imaging assessment including at least a cervical ultra-sound, a cervico-thoracic CT-scan and/or a cervico-thoraco-abdomino-pelvic CT-scan and a liver MRI.
  7. Patient able to be followed at least 6 months after PET 18-FDOPA.
  8. If women are breastfeeding, nursing should be discontinued during 24 hours after PET 18-FDOPA.
  9. Patient must provide written informed consent prior to any specific procedure or assessment.
  10. Patient must be affiliated to the French Social Security System.
  Exclusion Criteria:
  1. Pregnant patient.
  2. Post-operative radiotherapy initiated before PET 18-FDOPA.
  3. Patient with PET 18-FDG performed within 24 hours before PET 18-FDOPA.
  4. Participation in any other clinical trial for therapeutic use.
  5. Patient with PET / CT-scan exam contra-indication.
  6. Any serious and/or unstable pre-existing psychological, familial, geographic or social condition that could interfere with medical follow-up and compliance to study procedures.
  7. Patient protected by law.

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion

Summary: Larotrectinib (LOXO-101) expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion who are ineligible for an ongoing larotrectinib (LOXO-101) clinical trial or have other considerations that prevent access to larotrectinib (LOXO-101) through an existing clinical trial. Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion.


Eligibility: Inclusion Criteria:
  -  Diagnosis of cancer with a NTRK1, NTRK2, or NTRK3 gene fusion
  -  Are unable to participate in an ongoing larotrectinib (LOXO-101) clinical trial
  -  Willing and able to provide written, signed informed consent
  -  Medically suitable for treatment with larotrectinib (LOXO-101)
  Exclusion Criteria:
  - Currently enrolled in an ongoing clinical study of larotrectinib (LOXO-101) or another TRK inhibitor

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Metabolomics and Genetic Diagnosing Pancreatic Neuroendocrine Tumors in MEN1 Patients

Summary: Objectives:
  The aim of the present study is to assess the significance of metabolomics and genetics in diagnosing and survival evaluation for pNET in the periodic follow-up of MEN1 patients.
  Aim 1: To evaluate the relationship of serum global metabolic profiles with subsequent development of aggressive PNET and evaluate patients survival in a nested case-control study of MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have developed non-aggressive PNETs (controls).
  Aim 2: Validate the top serum metabolites identified from Aim 1 in MEN1 patients who have developed aggressive PNETs and MEN1 patients who have developed non-aggressive PNETs, using a targeted metabolomics approach.
  Aim 3: Prospectively identify the potential miRNA biomarkers of serum with miRNA sequencing in MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have developed non-aggressive PNETs (controls).
  Aim 4: Validate the potential miRNA biomarkers identified from Aim 1 in MEN1 patients who have developed aggressive PNETs and in MEN1 patients who have developed non-aggressive PNETs, using a targeted qRT-PCR approach (in serums), as well as to see the relationship of potential miRNA biomarkers with patients survival.


Eligibility: Inclusion Criteria:
  1. The study will include all patients with a confirmed MEN1 diagnosis (clinical, genetic or familial criteria).
  2. No prior history of PNET.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Expanded Access to RXDX-105 for Cancers With RET Alterations

Summary: Expanded access to RXDX-105 will be given to patients with cancers harboring RET alterations who have not received TKIs that target RET alterations, who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for RXDX-105.


Eligibility: Inclusion Criteria:
  -  Diagnosis of advanced cancer with RET alterations
  -  Unable to participate in an ongoing RXDX-105 clinical trial
  -  Willing and able to provide written, signed informed consent
  -  Medically suitable for treatment with RXDX-105
  Exclusion Criteria:
  -  Prior treatment with a TKI that has activity against RET alterations
  -  Currently enrolled in an ongoing clinical study with any other investigational agent

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)

Summary: The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH) who undergo surgery.

Detailed description: Researchers aim to identify somatic mutations and inherited genetic variants which may help predict the development of PNET in patients with hyperparathyroidism.

Eligibility: Inclusion Criteria:
  1. MEN1 patients who have undergone parathyroidectomy and did not develop PNET.
  2. MEN1 patients who have undergone parathyroidectomy and had surgical removal of PNET.
  Exclusion Criteria:

Relevance to patient case: not relevant