araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Oral TRK Inhibitor LOXO-101 for Treatment of Advanced Adult Solid Tumors

Summary: This is a multicenter, open-label, Phase 1 study of orally administered larotrectinib in adult subjects with advanced solid tumors that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists.

Detailed description: The trial will be conducted in 2 parts: an initial dose escalation phase of larotrectinib in subjects with advanced solid tumors. This will be followed by an expansion phase in solid tumor subjects with an NTRK fusion, documented alteration of the TRK gene or investigator documentation of perceived benefit from a TRK targeted agent. During the escalation phase, larotrectinib will be taken once daily (QD) or twice daily (BID). During the expansion phase, the larotrectinib dose selected from the escalation phase will be explored in approximately 40 additional subjects.
  The objectives of the dose escalation phase are to determine the safety, tolerability, pharmacokinetic profile, and recommended dose of orally administered larotrectinib. The objectives of the expansion phase are to better characterize the safety and efficacy of larotrectinib in patients with specific NTRK genes or proteins, or patients who, in the opinion of the Investigator, may derive benefit from a highly selective TRK inhibitor such as larotrectinib.

Eligibility: Escalation Phase [Inclusion]
  -  Locally advanced or metastatic adult solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists;
  -  ECOG score of 0, 1 or 2;
  -  Adequate hematologic, hepatic, and renal function;
  Expansion Phase [Inclusion]
  -  Escalation Phase inclusion criteria
  -  Evidence of the NTRK or TRK molecular characteristic as specified for that cohort, such as an NTRK translocation, amplifications, mutations or other alterations that may interfere with TRK signaling as previously determined with prior testing from a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalent certified laboratory. Additionally, patients who, in the opinion and clinical judgement of the local Investigator, may derive benefit from a targeted TRK inhibitor like larotrectinib, may also enroll.
  Exclusion (for both Escalation and Expansion)
  • Current treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor or inducer (EIAEDs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed)

Relevance to patient case: possibly relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer

Summary: Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. Perfusion MRI uses faster imaging. It also includes a contrast material that is given by vein. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.
  Perfusion and diffusion MRI give extra information which is not available with the regular MRI. A regular MRI only shows pictures of the tumor. Thyroid MRI scans are not part of the current standard of care. The purpose of this study is to see if new MRI methods can give us more information about the tumor.

Detailed description: The aim of this pilot study clinical trial is to provide MRI biomarkers as quantitative (surrogate) biomarkers of aggressiveness in papillary thyroid cancer (PTC) including PMCs and to lay out the scientific basis for their translation into patient management. In this study we will perform specially designed diffusion weighted MRI (DW-MRI) and dynamic contrast agent MRI (DCE-MRI) protocols in the PTC patients.
  DW-MRI allows for quantifying water diffusion which has been shown to be related to tumor cellularity (29). Particularly, appropriate modeling with DW-MRI data acquired at multiple b values will enable quantifying tumor cellularity and vascularity simultaneously (30-32). DCE-MRI with proper compartmental modeling will yield metrics related to tumor-vessel permeability, tumor perfusion, and extracellular-extravascular volume fraction (33, 34). These facts provide the potential of DW-MRI and DCE-MRI metrics as quantitative imaging biomarkers of tumor aggressiveness in PTCs. The DW-MRI and DCE-MRI may ultimately help in personalized management approach, in which imaging biomarkers may be used to recommend either immediate surgery or active surveillance for PTC patients.

Eligibility: Inclusion Criteria:
  -  Biopsy proven Papillary Thyroid Cancer (regardless of genotype and including all subtypes such as follicular or mixed papillary follicular) or suspicious for Thyroid Cancer
  -  Thyroidectomy or lobectomy planned as definitive treatment for Thyroid Cancer or patients on active surveillance management approach
  -  Age ≥18 years
  Exclusion Criteria:
  -  Patient would require anesthesia for the study
  -  Patients who are claustrophobic Patients with tumor size greater than 5 cm in diameter as measured at imaging (ultrasonography or MRI) before treatment
  -  Patients who have presence of a known contraindication to MRI
  -  Pacemaker
  -  Aneurysmal clips
  -  Metal implants in field of view
  -  Pregnant
  -  Age and mental status wherein he/she is unable to cooperate for MRI study Patients who have presence of a known contraindication to DCE-MRI may not participate in that portion of the study
  -  Known reaction to Gd-DTPA, contrast agent
  -  Chronic kidney disease
  -  nursing women

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: MVX-ONCO-1 in Patients With Solid Tumor

Summary: The objectives are to assess the safety and tolerability of 6 vaccine doses of MVX-ONCO-1, administered sub-cutaneously (injections and capsules implantations), in patients with advanced metastatic solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease.

Detailed description: Endpoints:
  Primary: To assess safety parameters including adverse and serious adverse events (incidence, causality, severity), local and systemic tolerance to the administered study treatment, changes in laboratory values and vital signs in patients with solid tumor; Secondary: to measure some tumor responses in using imaging technique, serological tumor markers, immune monitoring and metabolic monitoring.

Eligibility: Inclusion Criteria:
  -  Male or female patients aged 18 years and older with advanced metastatic cancer in progression of various sites [Carcinoma of lung (either small cell or non-small cell), colon, breast, pancreas (exocrine or endocrine), stomach, oesophagus, head&neck, thyroid, kidney, bladder, prostate, ovary, uterus (cervix or corpus); Sarcoma of soft tissue, bone, uterus, melanoma; primary brain tumor] where all recognized treatment are exhausted or not feasible.
  -  Life expectancy: estimate of at least 4 months.
  Exclusion Criteria:
  -  Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks.
  -  Have received any chemotherapy treatment in the 4 preceding weeks.
  -  Serious concomitant health condition such as organ transplant requiring immunosuppressive drugs, severe psychiatric disorders.
  -  History of second cancer within the last 2 years with the exception of basal cell carcinoma of skin and localized cervical carcinoma treated with curative intent.
  -  Patient with a systemic disease other than cancer, that is not controlled by usual medication.
  -  Therapeutic anticoagulation with coumarine or continues iv heparin. Low-molecular weight heparin (LMWH) is permitted as long as treatment can be withheld several hours prior to subcutaneous implantation.
  -  Positive HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B surface antigen, or hepatitis C antibody.

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors

Summary: Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal cancer or head and neck cancer in several phase II/III studies.
  Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase I/II studies in advance kidney cancer of bad prognosis.
  Study hypothesis is that combination of those two compounds and the inhibition of two pathways at the same time will have more efficiency on tumoral growth than the inhibition of those pathways in isolation.


Eligibility: Inclusion Criteria:
  -  Patients with malignant tumor confirmed histologically or cytologically who does not respond to usual therapeutics or for whom there is no curative treatment
  -  Age >/= 18 years
  -  ECOG 0 or 1
  -  Life expectancy >/= 12 weeks
  -  Grade </=1 for all adverse effects related to previous therapy or surgery (except for alopecia)
  -  Appropriate organic functions as defined:
  -  ASAT and ALAT </= 2.5xLSN or ASAT and ALAT </= 5xLSN in case of inappropriate hepatic function due to the underlying disease
  -  Bilirubin </= 1.5xLSN
  -  Albumin >/= 3.0 g/dL
  -  Neutrophil counts (PNN) >/= 1 500/mL
  -  Platelets >/= 100 000/mL
  -  Hemoglobin >/= 9.0 g/dL
  -  Creatinin </= 1.5xLSN
  -  Cooperative patients able to respect the protocol
  Exclusion Criteria:
  -  Treatment by chemotherapy, radiotherapy, surgery or the two compounds of the study within 4 weeks before the inclusion
  -  Previous treatment with an association of mTOR inhibitor or EGFR inhibitor
  -  Diagnosis of a secondary cancer within the last 3 years except for a basal-cell carcinoma, cutaneous spinocellular cancer or in situ carcinoma well treated
  -  Grade >/= 2 nephropathy according to NCI CTCAE
  -  Current treatment with curative dose of coumadin or heparin of low molecular weight
  -  Previous uncontrolled brain metastases, medullar compression or carcinomatosis meningitis or any proof of leptomeningeal pathology or metastasis.
  -  Presence of one og those pathologies during the last 12 months before the inclusion:
  -  myocardial infarction
  -  angina pectoris
  -  bypass of coronal or peripheral arteries
  -  heart failure
  -  stroke
  -  cerebral bleeding
  -  pulmonary embolism
  -  Grade 3 bleeding according to NCI CTCAE criteria less than 3 weeks before treatment start
  -  Uncontrolled high blood pressure (>150/100mhHg)
  -  Grade >/=2 heart rate disorder, atrial fibrillation whichever the grade, lengthen of QTC >450 msec for male or >470 msec for female.
  -  Patients HIV positive
  -  Pregnant or breastfeeding woman
  -  Patients with psychiatric disorder
  -  Active alcoholism
  -  Previous pulmonary interstitial disease
  -  Previous hypersensitivity to antihistamine treatment and/or medical contraindication for an antihistamine or corticoid treatment

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

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: possibly relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: A Study of DCC-2701 in Participants With Advanced Solid Tumors

Summary: The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body.

Detailed description: This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine what dose of DCC-2701, can be given safely to patients with advanced solid tumors.
  The study will have two phases. The first phase will assess escalating doses of DCC-2701 in order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.

Eligibility: Inclusion Criteria:
  -  Advanced or metastatic solid tumor that has progressed or was not responsive to standard therapy
  -  The cancer has no proven effective therapy
  -  The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
  -  Able to swallow tablets
  Exclusion Criteria:
  -  Have active central nervous system (CNS) metastasis
  -  Have an active infection of any kind (fungal, viral, or bacterial)
  -  Are pregnant or breastfeeding

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: APPLICATION OF MOLECULAR TECHNIQUES FOR IMPROVING THE DIAGNOSIS AND TREATMENT OF NODULAR THYROID LESIONS.

Summary: To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System)

Detailed description: Aim of the study To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System).
  Design: Retrospective observational study. Scope: The study will be peformed at the Pathology Service, from cytological samples and paraffin file post-diagnosis. Mutations are detected by pyrosequencing technique.
  Subject of study:
  Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí.
  Methodology:
  -  Identification of cases
  -  Detection of BRAF V600E mutation, initially in histological material from the surgical specimen, and if present, detection in cytological material.
  The statistical analysis will use SPSS. Univariate and bivariate analysis will be done. Results will be presented in the form of frequency tables and percentages for qualitative variables and by average, median and standard deviation for quantitative variables. Pearson chi-square or Fisher's exact test will be applied. The Student t test or the Mann-Whitney test will be performed for quantitative variables.

Eligibility: Inclusion Criteria:
  -  Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí
  Exclusion Criteria:
  -  Non available cytological or histological material

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Radiographic Contrast To Differentiate Cavitated From Non-cavitated Tooth Decay

Summary: The proposed test is intended to enable dentists to differentiate between cavitated and non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces). In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns, pain, root canals, and possible later loss of teeth.

Detailed description: Tooth sites will be recorded by both tooth number, type of surface (mesial, distal, occlusal), cavitated, non-cavitated, healthy. Radiographs will similarly be scored. Although contrast agents are classified as drugs this is not a study of drug properties or effect on cells since the properties of the agent are already well known and its safety record well established. This study will be recording the radiopacity of the contrast agent on healthy tooth surfaces, non-cavitated tooth surfaces and cavitated tooth surfaces. The outcome for each surface type will be presence or absence of a radiopacity on a radiograph which will be made at the one and only visit for each study subject. The radiograph contains the data from the intervention (placement of contrast agent) and the outcome will be assessed some weeks later after the completion of the data collection.

Eligibility: Inclusion Criteria:
  -  Must have a minimum of 2 adjacent teeth so that interproximal surfaces of interest are in contact and hidden from direct visual examination.
  The occlusal plane plane should be normal so that the interproximal contact regions are normal.
  English or Spanish speaker.
  Exclusion Criteria:
  -  Pregnant women. A person who has participated in a similar study involving dental radiography within the last 12 months.
  Fillings must not be present in the regions of interest.

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Genomic Predictors of Papillary Microcarcinoma Disease Progression

Summary: The purpose of this study is to identify specific clinical and molecular characteristics that are predictive of tumor progression in small thyroid cancers.


Eligibility: Inclusion Criteria:
  -  Biopsy proven papillary thyroid cancer (or suspicious for papillary thyroid cancer) confirmed by MSKCC cytopathologist.
  -  Being followed with active surveillance at MSKCC
  -  Biopsied index nodule less than or equal to 2 cm in maximum dimension
  -  Thyroid and neck US performed and interpreted by a MSKCC radiologist within 6 months prior to study entry.
  Exclusion Criteria:
  -  Biopsied index nodule greater than 2 cm in any dimension
  -  Age less than 18 yrs old

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients

Summary: Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique) could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as traditional BCS does. However, there are no prospective trial comparing oncoplastic-BCS vs. traditional BCS in terms of cosmetic outcomes and oncological safety. In this study, the investigators are going to address this issue by assigning patients into traditional and oncoplastic-BCS group, based on their preference.


Eligibility: Inclusion Criteria:
  -  Informed consent signed
  -  ECOG<=2
  -  Non-metastatic breast cancer patients with unilateral breast cancer confirmed by pathology.
  -  Operable or operable after neoadjuvant chemotherapy.
  -  Extensive, diffuse micro-calcifications on mammography before surgery
  -  No history of breast surgery or breast radiation therapy before.
  -  Able to follow the standard of care in adjuvant chemotherapy, radiation therapy, endocrine therapy and targeted therapy after surgery.
  Exclusion Criteria:
  -  Multifocal/multicentric diseases noticed before surgery.
  -  Inflammatory breast cancer or invasive micro-papillary carcinoma of the breast confirmed by pathology before surgery.
  -  Tumor size > 5 cm revealed by physical examination, Ultrasound or mammography before surgery.
  -  Tumor size/breast size ratio >0.5 revealed by by physical examination, Ultrasound or mammography before surgery.
  -  Have other malignant tumors.
  -  Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients.
  -  Participated in other clinical trials.
  -  Pathologically confirmed metastatic breast cancer, bilateral breast cancer or DCIS patients.
  -  Patients with any organ failure.
  -  Pregnancy women
  -  Patients who desire to have mastectomy before surgery.

Relevance to patient case: not relevant
Patient case: 46-year-old female with papillary thyroid carcinoma; genetic feature: NTRK1

Clinical trial: The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma

Summary: The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.

Detailed description: The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma. Primary outcome is the structural recurrence rate. Secondary outcomes are operative time, postoperative complications, and quality of life.
  The enrolled patients were randomly assigned to control group and intervention group (1:1 allocation).

Eligibility: Inclusion Criteria:
  -  no clinical and radiological evidence of lymph node metastasis
  -  no evidence of hyperparathyroidism
  Exclusion Criteria:
  -  pregnant women
  -  uncontrolled diabetes, hypertension, or chronic renal failure
  -  aspirin or anticoagulant medication within 7 days
  -  other clinical trial participation within 30 days
  -  radiation exposure to the head and neck
  -  previous operation to the neck
  -  advanced thyroid cancer including adjacent organ invasion

Relevance to patient case: not relevant