araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

Clinical trial: Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors

Summary: This study is a single-arm,phase II study of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.
  Gefitinib 250 mg will be administered orally daily.
  To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. Patient with Epidermal growth factor receptor amplification Refractory Solid Tumors and/or specific sensitivity to Gefitinib by Avatar scan that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  (EGFR amplification by cancer scan + EGFR IHC overexpression +2 or +3)
  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 ≥ 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 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. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
  7. Any previous treatment with Gefitinib
  8. Patients with a risk factor of interstitial lung disease

Relevance to patient case: not relevant
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

Clinical trial: Re-Examination of Tumor Material and Re-Evaluation of Patient Data From Patients Treated With Neo-adjuvant Therapy

Summary: This is a prospective examination of ribonucleic acid (RNA) extracted from tumor material of breast cancer patients treated with a neo-adjuvant therapy. The RNA will be analysed for expression of estrogen receptor (ER 1), progesterone receptor (PgR), HER2 and Ki-67 with MammaTyper™.
  According to the determined values for the individual parameters at least 4 subtypes can be distinguished to date
  -  Luminal A-type
  -  Luminal B-type
  -  HER2-type
  -  Triple-negative-type As non-clinical endpoint, the agreement of new subtyping with Immunohistochemical methods will be evaluated.
  As clinical objective, the 5 year Distant metastasis free survival (DMFS) and Overall survival (OS) will be reevaluated according to the new subtyping.

Detailed description: Tumor material collected from patients who received neoadjuvant therapy either with four cycles of doxorubicin 60 mg/m² plus pemetrexed 500 mg/m² on day 1 every 21 days followed by four cycles of docetaxel 100 mg/m² on day 1 every 21 days or four cycles of doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² on day 1 every 21 days followed by four cycles of docetaxel 100 mg/m² on day 1 every 21 days will be re-analyzed with the MammaTyper Kit. The Kit is an in-vitro molecular diagnostic test for molecular subtyping of breast cancers into Luminal A & B, HER2 and Triple negative. It allows quantitative detection of the RNA expression status of the genes for estrogen receptor (ESR1), PgR, HER2 and Ki-67 on the basis of their mRNA present in the samples. This prospective diagnostic study will investigate the subtyping-results of the MammaTyper™ analysis and will compare them to the subtyping of the former immunohistochemical analysis performed. Based on the MammaTyper™-subtypes the efficiency of the therapy regimen and the outcome will be re-evaluated from the patient data.

Eligibility: Inclusion Criteria:
  -  Women aged 18-70 years with histologically confirmed primary invasive breast cancer stages T2-T4/N0-N2/M0 with a tumor size of ≥ 2 cm as measured by ultrasound
  -  The patient provides a written informed consent for analysis of tumor material
  Exclusion Criteria:
  -  Prior anticancer therapy with an anthracycline or other prior antitumor therapy for breast cancer
  -  Inflammatory or exulcerating breast cancer
  -  A second primary malignancy [except carcinoma in situ (CIS) of the cervix or adequately treated nonmelanoma skin cancer] unless diagnosed and treated ≥ 5 years ago with no evidence of recurrence
  -  Any serious concomitant systemic disorder

Relevance to patient case: not relevant
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

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: possibly relevant
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

Clinical trial: "Solana™ Trichomonas Assay Field Study"

Summary: The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Helicase-Dependent Amplification (HDA) technology and the Solana instrument.

Detailed description: This study is to establish the clinical performance of the Solana® Trichomonas Assay for the detection of Trichomonas vaginalis in vaginal swabs and urine samples as compared to a combined reference method of direct wet mount microscopy and a FDA-cleared device.

Eligibility: Inclusion Criteria:
  -  Female subjects will be recruited from the general population as they present to the clinical facility. Subjects will be categorized by the clinician as either asymptomatic or symptomatic for Trichomonas vaginalis infection.
  Symptoms in women can include:
  -  Greenish-yellow, frothy vaginal discharge with a strong odor
  -  Painful urination
  -  Vaginal itching and irritation
  -  Discomfort during intercourse
  -  Lower abdominal pain (rare)
  Exclusion Criteria:
  1. The study is limited to females. Male subjects are not accepted.
  2. At clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Relevance to patient case: not relevant
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

Clinical trial: Platinum Rechallenge in Patients With Platinum-sensitive mTNBC

Summary: Platinum Retreated in Patients with Platinum Sensitive mTNBC

Detailed description: Platinum Retreated in Second- or Third-line Patients with Platinum Sensitive Metastatic Triple Negative Breast Cancer (randomised, phase II, NPN trial)

Eligibility: Inclusion Criteria:
  1. Females with age between 18 and 70 years old
  2. Performance status no more than 2
  3. Life expectancy longer than 3 months
  4. Histological proven unresectable recurrent or advanced breast cancer
  5. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+).
  6. Patients must have progressed after 1or 2 prior chemotherapy regimens for metastatic disease, cis/carbo-platin pretreated only 1 previous line prior to randomisation. Platinum sensitive in this study is defined as complete or partial or stable disease following completion (a minimum of 4 treatment cycles) of previous platinum-based chemotherapy and disease progression greater than 3 months after completion of their last dose of platinum chemotherapy (last dose).
  7. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
  8. Radiation therapy within 4 weeks prior to enrollment
  9. All patients enrolled are required to have adequate hematologic, hepatic, and renal function
  10. Be able to understand the study procedures and sign informed consent.
  Exclusion Criteria:
  1. Patients had prior treatment with vinorelbine
  2. Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
  3. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
  4. Treatment with an investigational product within 4 weeks before the first treatment
  5. Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
  6. Uncontrolled serious infection
  7. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.

Relevance to patient case: not relevant
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

Clinical trial: Liquid Biopsy in Monitoring the Therapeutic Efficacy of Targeted Therapy in Advanced/Metastatic Gastric Cancer

Summary: To evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in histologically confirmed HER2 positive advanced/metastatic gastric cancer.

Detailed description: The study is a single-center, prospective study undertaken in anticipated 100 patients with histologically confirmed HER2 positive advanced/metastatic gastric cancer. Peripheral blood samples of 12.5 mL were collected from the patients for cfDNA and CTCs analysis. The blood samples will be respectively drawn before therapy, at the time that the patients achieve the optimal response and when they suffer progressive disease. The enumeration of CTCs as well as the detection of HER2 expression will be achieved via the integrated subtraction enrichment (SET) and immunostaining-fluorescence in situ hybridization (iFISH) platform. Further, for the geneomic analysis, the enriched single CTC will be isolated for single-cell targeted sequencing. While for cfDNA analysis, extracted DNA from plasma will be directly subjected to targeted sequencing. The correlation of the HER2 status on CTCs and the HER2 amplification in cfDNA to the therapeutic response will be evaluated. Moreover, gene variations associated with resistance in HER2-targeted therapy will be also studied based on the genomic data from sequencing of CTC and cfDNA.

Eligibility: Inclusion Criteria:
  -  Having signed informed consent
  -  Age≥ 18 years old
  -  Histologically confirmed HER2 positive gastric adenocarcinoma
  -  Unresectable recurrent or metastatic disease
  -  Measurable disease according to the RECIST criteria
  -  Karnofsky performance status ≥60
  -  Life expectancy of ≥2 month
  -  ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
  -  Serum albumin level ≥3.0g/dL
  -  Serum AKP < 2.5 times ULN
  -  Serum creatinine <ULN, and CCr < 60ml/min
  -  Bilirubin level < 1.5 ULN
  -  WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl
  Exclusion Criteria:
  -  Brain metastasis (known or suspected)
  -  Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry. Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
  -  Allergic constitution or allergic history to protium biologic product or any investigating agents.
  -  Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
  -  Pregnancy or lactation period
  -  Other previous malignancy within 5 year, except non-melanoma skin cancer
  -  Pre-existing neuropathy>grade 1
  -  Legal incapacity

Relevance to patient case: not relevant
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

Clinical trial: A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)

Summary: The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in subjects with unresectable or metastatic melanoma


Eligibility: Inclusion Criteria:
  -  Have histologically or cytologically confirmed melanoma
  -  Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy
  -  A minimum of 1 measurable lesion by CT or MRI
  -  Provide a baseline tumor biopsy
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  Exclusion Criteria:
  -  Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy)
  -  Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting
  -  Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)
  -  Has an active infection requiring systemic therapy
  -  Has known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  -  Has known history of or is positive for Hepatitis B or Hepatitis C
  -  Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment

Relevance to patient case: not relevant
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

Clinical trial: Combined Training on Body Composition of Postmenopausal Women Undergoing Treatment for Breast Cancer

Summary: Breast cancer is a multifactorial disease affecting women, and one of the treatments for its healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that promote lower chance of metastasis, but their side effects include the loss of bone mineral density and increased fat percentage. In this way, the Combined Training (combined resistance and endurance training) may be an interesting strategy to minimize the side effects of aromatase inhibitors, providing better quality of life, survival and changes in body composition.


Eligibility: Inclusion Criteria:
  -  Postmenopausal, defined by the absence of periods for the past 12 months;
  -  Breast cancer diagnosis stages 1 to 3;
  -  The adjuvant treatment for breast cancer and / or neoadjuvant aromatase inhibitors
  -  No abnormalities on screening physical or any health problems that contraindicate study participation;
  -  No contraindications for treadmill testing or entry into a training program, including any of the following:
  -  Myocardial infarction within the past 6 months
  -  Pulmonary edema
  -  Myocarditis Pericarditis
  -  Unstable angina
  -  Pulmonary embolism or deep vein thrombosis
  -  Uncontrolled hypertension (i.e., blood pressure > 200/100 mm Hg)
  -  Uncontrolled arrhythmia
  -  No significant mental illness
  -  Have medical certificate to perform exercise testing and participate in combined training
  -  Able to answer Questionnaires
  -  No concurrent participation in any other organized exercise program;
  -  Live in Presidente Prudente
  -  Sign the consent form and formal clarification for participation in the study.
  Exclusion Criteria:
  -  Accumulating 3 unexcused absences or 4 consecutive unexcused absences during the month.

Relevance to patient case: not relevant
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

Clinical trial: The Effects of Perioperative Dexmedetomidine Administration on Immune Suppression and Outcomes in Patients With Uterine Cancer Undergoing Radical Resection

Summary: Surgical stress and anesthesia may cause immunosuppression in immunocompromised cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity. Dexmedetomidine has sympatholytic effect and preserves NK cell function. This study investigate the effect of dexmedetomidine on immune suppression and postoperative outcomes in patients undergoing uterine cancer resection.


Eligibility: Inclusion Criteria:
  -  patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
  -  patient scheduled for uterine cancer surgery
  Exclusion Criteria:
  -  ASA physical status Ⅳ
  -  severe hepatorenal disease
  -  infection
  -  metastasis to other organ
  -  problem with communication

Relevance to patient case: not relevant
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

Clinical trial: Effects of Two Aquatic Training Models in Physiological Parameters of Elderly Dyslipidemic Women.

Summary: This study aims to compare the effects of two water-based training models in physiological parameters of dyslipidemic elderly women. Thus, a randomized controlled clinical trial will be conducted in parallel with the participation of 45 dyslipidemic elderly women.

Detailed description: The women will be randomly divided into three groups: water aerobics training (WA), resistance aquatic training (WR) and the third is the control group (who will perform relaxation sessions under water). The three groups will attend classes during 10 weeks, with two weekly sessions of 45 minutes each. The WA and WR groups will use the same four exercises in their training.
  The WA group will be trained using the interval method, performing six blocks of five minutes each one, alternating four minutes at intensities corresponding to 90 to 100% of the heart rate corresponding to the second ventilatory threshold (HRVT2) and one minute at intensities between 80 and 90% HRVT2.
  The WR group will perform four to eight sets of 20 to 10 seconds along the macrocycle, always at maximal speed execution of the exercises.
  Will be measured, before and after the period of 10 weeks of intervention, biochemical, cardiorespiratory, neuromuscular and hemodynamic variables, parameters of quality of life and depressive symptoms in addition to the cardiovascular risk score of the participants of the three groups.
  Data will be described by means values and lower and upper limits, with a 95% confidence interval. Comparisons between and within groups were performed using the method of generalized estimates of equations (GEE), with Bonferroni post hoc, adopting a 0.05 significance level.

Eligibility: Inclusion Criteria:
  -  being female, aged between 60 and 75, sedentary (not practicing any kind of regular, supervised physical activity in the last three months), have any type of dyslipidemia.
  Exclusion Criteria:
  -  women who are smokers, suffering from cardiovascular disease with associated complications and those with orthopedic diseases that prevented the practice of systematic physical exercise, users of hormone therapy drugs and lipid-lowering medications.

Relevance to patient case: not relevant
Patient case: 66-year-old female with melanoma; genetic feature: KIT amplification

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