araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: The ED50 of DEX for Providing Sedation in Different Female Age Group

Summary: Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age, and current studies with regard to the effects of age on dexmedetomidine pharmacodynamic are rare. This study was designed to explore the right DEX dose of different female Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of sedation for patients is also investigated.

Detailed description: 90 patients scheduled for combined spinal epidural spinal anesthesia were included in one of three groups. In each group,determination of median effective (ED50) doses was performed by the Dixon up-and-down method, an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1 μg/kg in first three turning points and 0.05μg/kg in the last three turning points.Initial doses was 1.4μg/kg, .Sedative efficacy was defined as an OAA/S of ≤3,30 min after the beginning of drug administration.

Eligibility: Inclusion Criteria:
  1. ASA Ⅰ ~ Ⅱ patient undergoing lower extremity surgery
  2. Written informed consent from the patient or the relatives of the participating patient.
  3. BMI:18.0～25.0kg/m2
  Exclusion Criteria:
  1. Mental illness can not match
  2. epidural anesthesia contraindicated
  3. People who have Slow-type arrhythmias
  4. People who were language or hearing impaired
  5. Sensory block reached to T8 or higher.
  6. People who had lung infection or sleep apnea syndrome.
  7. Pregnancy
  8. Chronic renal failure
  9. Alcohol or drug abuse
  10. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors

Summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.


Eligibility: Inclusion Criteria:
  -  For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.
  -  For dose escalation for all combinations: The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.
  -  For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  -  For Part B dose confirmation: All participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  -  For Part C dose confirmation: All participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  -  For Part D dose confirmation: All participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease).
  -  For Part E dose confirmation: All participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (TNBC) and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >2 lines of systemic treatment for advanced or metastatic TNBC.
  -  Have adequate organ function.
  -  Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  -  Have discontinued all previous therapies for cancer.
  Exclusion Criteria:
  -  Have current acute leukemia.
  -  Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Observational Study on Endometrial Stromal Tumors

Summary: Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)

Detailed description: Observational, retrospective and prospective study on EST aimed to understand more about its biology, natural history and antitumor activity of different treatment options.
  This study will collect data in prospective and retrospective way of patients affected by EST and treated according disease guidelines and local practices.
  The study will also review the diagnosis by a central expert pathologist in order to its confirmation

Eligibility: Inclusion Criteria:
  -  patients with a diagnosis of Endometrial Stromal Tumor (EST) according to the World Health Organization (WHO) classification 2003 or 2014
  -  Informed consent signature
  Exclusion Criteria:
  -  patients with different diagnosis from EST

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Detection of Circulating Tumor Cells in Patients With Sarcomas

Summary: The sarcomas represent 1% of all cancers in adults, 8% in adolescents and young people, and 10% in children. Even though it is a rare cancer, it contributes to a significant loss of years of life in comparison with other types of cancer, due the fact that it affects children and young people. The diagnosis and treatment are difficult, considering the diversity and rarity of this disease. In addition, on average, more than 50% of patients with high-grade sarcoma present tumor relapse and distant recurrence is considered the main cause of death. The presence of Circulating Tumor Cells (CTCs) in the blood of patients with sarcoma may be an early marker of tumor invasion, because it is known that the CTCs circulate in the blood for months or years before the development of metastases. The CTCs can be used to monitor the response of the tumor to treatment, in order to match time, dose, and type of therapy.
  Objectives: collect blood from patients with different types of sarcoma (leiomyosarcoma, synovial sarcoma, pleomorphic sarcoma and liposarcoma) in order to isolate and quantify CTCs. The investigators also have an intention to identify genes of resistance to treatment in these cells.

Detailed description: Methodology: This is a prospective study, to be made by whole blood collection from 40 patients with different types of sarcomas (leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma). The collections will be made in three different moments: before the beginning of the treatment, during and at the end of this (8 mL). Blood samples will be processed and filtered on ISET system for the isolation and quantification of CTCs. Later, it will be performed immunocytochemistry (ICQ) single and/or double staining for protein assessment. The following proteins will be assessed: CD45, MRP1, MRP2 and MRP7.
  Expected Results: The investigators hope that this study can show if the CTCs can be used as "liquid biopsy" in patients with leiomyosarcoma, synovium and pleomorphic sarcoma and liposarcoma.

Eligibility: Inclusion Criteria:
  -  18 years or more;
  -  types of sarcomas: leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma.
  -  extension of the disease determined by physical examination and imaging;
  -  measurable disease by RECIST criteria (Response Evaluation Criteria in Solid Tumors);
  Exclusion Criteria:
  -  patients who have undergone previous therapy in the last three weeks;
  -  patients with a history of other cancer in the past two years.

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Trial On Trabectedin In The Treatment Of Advanced Uterine And Ovarian Carcinosarcoma (CS)_MITO 26

Summary: Multicenter phase II study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. Patients will receive trabectedin until disease progression or unacceptable toxicity. Disease response evaluation will be assessed every 9 weeks.

Detailed description: This is a Phase II, multi-centre, single arm study aiming at evaluating efficacy and toxicity of Trabectedin in a population of advanced or recurrent ovarian and uterine carcinosarcoma.
  Trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.

Eligibility: Inclusion Criteria:
  -  Histologically documented Stage I-IV or recurrent uterine or ovarian carcinosarcoma not amenable to surgery or radiotherapy
  -  No more than 2 previous chemotherapy lines
  -  PS 0-2 (ECOG)
  -  Age> 18
  -  Measurable disease
  -  Life expectancy of at least 3 months
  -  Adequate organ functions:
  -  Hematopoietic; Absolute neutrophil count ≥ 1,500/mm^3; Platelet count ≥ 100,000/mm^3; Hemoglobin ≥ 9 g/dL Hepatic; AST and ALT ≤ 1.5 times upper limit of normal (ULN)*; Protocol Version 1.0_05.09.2016 6 Alkaline phosphatase ≤ 2.5 times ULN*; Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 3 times ULN if liver metastases are present Renal; Creatinine Clearance ≥ 45 mL/min or Serum Creatinine ≤1.5 x ULN Serum Albumin >3.0 g/dL
  -  Previous Brachytherapy treatment for uterine carcinosarcoma is allowed
  -  No other invasive malignancy within the past 3 years except non-melanoma skin cancer
  -  Written Informed Consent
  Exclusion Criteria:
  -  More than 2 previous chemotherapy lines
  -  Single tumor lesion inside a previous irradiated filed
  -  Pregnant (potentially fertile patients must be not in pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test)
  -  Active infection requiring antibiotics
  -  Symptomatic peripheral neuropathy > grade 2 according to the NCI Common Toxicity Criteria.
  -  Congestive heart failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia.
  -  Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with achievement of study objectives
  -  Psychological or sociological conditions, addictive disorders, or family problems, which would preclude compliance with the protocol

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma

Summary: Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.
  More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.

Detailed description: Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.
  More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.

Eligibility: Inclusion Criteria:
  Diagnosis: Confirmed translocation-positive Ewing sarcoma
  Organ Function Requirements:
  Serum creatinine < 1.4 Adequate liver function
  -  Total bilitubin <1.5x upper limit of normal for age
  -  SGPT (ALT) < 5x upper limit of normal for age Adequate cardiac function > 50% by echocardiogram Bone Marrow
  -  Absolute neutrophil count > 750
  -  Platelet count > 75
  Exclusion Criteria:
  -  Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained. Lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy. Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy.
  -  Patients with known pre-existing diabetes mellitus will be excluded from study.

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO™ Device in Soft Tissue Sarcoma

Summary: This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.

Detailed description: This is a single arm, pilot study designed to test the feasibility of using the CIVO (Comparative In Vivo Oncology) system in patients with soft tissue sarcoma accessible for percutaneous injection. Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected one to three days prior to surgery using the CIVO device. Minute volumes (up to 8.3 microliters) of saline (negative control) or microdoses of anti-cancer agents will be percutaneously injected in a columnar fashion through each of 8 needles into a single enlarged solid tumor. Following the patient's biopsy surgery or tumor resection surgery, the injected portion and a small uninjected portion will be used to determine the in situ drug response in the tumor. None of the data from this evaluation will be shared with patients or used to make clinical decisions. Study clinicians will have access to the patient's health record for 1 year after the study to monitor patient treatment responses. Such information will be used to help evaluate the correlation between clinical response and tumor response assessed via CIVO.

Eligibility: Inclusion Criteria:
  -  18 years of age or over.
  -  At least one soft tissue sarcoma tumor that is considered accessible for percutaneous injection by the investigator and that is at least 3 cm in longest dimension.
  -  Prior surgical evaluation and plan for surgical biopsy or surgery to remove the tumor being injected.
  -  ECOG performance status of 0-2 (or a Karnofsky performance status of >50%) (Appendix B).
  -  Labs required for enrollment (prior to microinjection):
  -  Absolute neutrophil count > 1000/mm3
  -  Platelet count > 50,000/mm3
  -  hematocrit > 25%
  -  Creatinine <3,0 mg/dl
  -  Total bilirubin <4,0 mg/dl
  -  Bilirubin <4,0 mg/dl, SGOT ≤ 1.5 times the upper limit of normal
  -  PT and PTT ≤ 1.5 times the upper limit of normal
  Exclusion Criteria:
  -  Any therapy that is potentially immunosuppressive or has anti-cancer activity in the 4 weeks prior to device microinjection.
  -  Subjects with active fungal, viral, or bacterial infections.
  -  Pregnant women.
  -  Inability to give informed consent.
  -  Current treatment with anticoagulation such as warfarin or low-molecular-weight heparin.
  -  Tumors near critical structures such as those located near or in the brain or spine. This judgement will be determined by the treating clinician.

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: A Phase II Study of Apatinib in STS Patients

Summary: Apatinib is a kind of innovative medicines approved by China Food and Drug Administration（CFDA）, which was researched by Jiangsu Hengrui Pharmaceutical Co., Ltd. Apatinib is a kinase inhibitor of receptor tyrosine with VEGFR2. The protocol is to explore Apatinib for the effectiveness of advanced soft tissue sarcoma and safety.


Eligibility: Inclusion Criteria:
  -  Signed informed consent.
  -  Histologically proven advanced soft tissue sarcoma, At least one measurable lesion. Including: Synovial sarcoma, leiomyosarcoma, Alveolar soft part sarcoma, Undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Clear cell sarcoma, Epithelioid sarcoma, Angiosarcoma, Spindle cell sarcoma, rhabdomyosarcoma treated by chemotherapy, Ewing's sarcoma of soft tissue/Primitive neuroectodermal tumor. Excluding: Malignant peripheral nerve sheath tumor, chondrosarcoma, Dermatofibrosarcoma protuberans, Gastrointestinal stromal tumor, Inflammatory myofibroblastic sarcoma, Malignant mesothelioma.
  -  Must have evidence of unresectable residual disease.
  -  In the last 6 months, at least one chemotherapy regimen (including anthracyclines) was used in patients who failed or were unable to tolerate treatment.
  -  ECOG ps≤2.
  -  Life expectancy: more than 3 months.
  -  Prior aptinib less than 2 weeks and at least 1 month since prior aptinib；at least 1 month since prior inhibitor of mTOR or EGFR pathway.
  -  Not pregnant or nursing；Fertile patients must use effective contraception.
  -  Hematopoietic
  -  HB≥90g/L
  -  Absolute neutrophil count ≥ 1,500/mm^3
  -  Platelet count ≥ 80,000/mm^3
  Exclusion Criteria:
  -  Uncontrollable hypertension;
  -  Has influence of oral drugs;
  -  Patients with high risk of gastrointestinal blooding;
  -  INR>1.5×ULN，APTT>1.5×ULN;
  -  Allergic to any ingredient of this product;
  -  Less than 1 month since last major surgery;
  -  Brain metastases;
  -  With the second cancer.

Relevance to patient case: not relevant
Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Phase I Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Plus GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) Plus Dose Escalation of IL-3 (Interleukin-3) in Metastatic Breast Cancer

Summary: This is a phase I study to determine the maximal tolerated dose of IL-3 given alone or sequentially with GM-CSF following FLAC chemotherapy in metastatic breast cancer patients.

Detailed description: Phase I study to determine the maximal tolerated dose of IL-3 given alone or sequentially with GM-CSF following FLAC chemotherapy.

Eligibility: Patients with Stage IV (metastatic) breast cancer are eligible who have a histologically-proven diagnosis. Measurable disease is not a prerequisite. Patients with Stage III disease or Stage ll with 7 or more nodes positive are eligible.
  Patients who have had prior adjuvant chemotherapy and/or hormonal therapy are eligible providing the regimen did not include adriamycin. Patients who have had prior radiation therapy may be eligible providing there was not extensive radiation to the cardiac area or to greater than 20% of the bone marrow.
  Patients who have received greater than 360mg/m2 of adriamycin as adjuvant therapy are ineligible.
  Patient must be previously untreated with chemotherapy for metastatic disease.
  There must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years.
  Performance status (Karnofsky scale) must be greater than 70; ECOG 0-2.
  Absolute granulocyte count greater than 1500/mm3 and platelet count greater than 100,000/mm3.
  Liver function tests (SCOT, Alk, Phosph., and T. Bili) should be less than 1.5 time the upper limits of normal. Serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min unless these abnormalities are due to tumor involvement.
  The patient must be able to give an informed consent, and to return to NCI for treatment and adequate follow-up for the period the protocol requires.
  No pregnant patients may be entered on this study; all patients should be informed about the need for contraception.
  Patients must be greater than or equal to 18 years of age.
  No patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol.
  No patients with a history of cardiac disease must have a normal ejection fraction by MUGA Scan and have no angina. Patients who have received prior adriamycin must have a LVEF greater than 45%.
  No history of CNS metastasis, or known seizure disorder.
  No allergy to any study medication.
  No pregnant or lactacting women.
  No patients requiring ongoing therapy for asthma.
  No patients with bleeding disorders.

Relevance to patient case: not relevant