araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer

Summary: The purpose of this study is to determine the safety and tolerability of three intratumoral injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended phase II dose of VCN-01 combined with Abraxane®/gemcitabine.

Detailed description: Investigational treatment is a dose-escalation regimen consisting of three VCN-01 intratumoral injections (once every 28 days at the same dose) in combination with intravenous Abraxane® and gemcitabine.

Eligibility: Inclusion Criteria:
  -  Male/Female patients aged 18 years or over
  -  Patients must provide written informed consent
  -  Life expectancy above 3 months
  -  Patients willing to comply with treatment follow-up, and to accept a biopsy at day 29 after initiation of the treatment
  -  Patients with histologically confirmed diagnosis of unresectable pancreatic adenocarcinoma with symptoms related to the primary tumor. Abraxane® plus Gemcitabine should be the appropriate standard of care to be administered.
  -  ECOG Performance status 0 or 1
  -  Adequate baseline organ function (hematologic, liver, renal and nutritional)
  -  Use a reliable method of contraception in fertile men and women
  Exclusion Criteria:
  -  Active infection or other serious illness or autoimmune disease
  -  Treatment with live attenuated vaccines in the last three weeks
  -  Known chronic liver disease (liver cirrhosis, chronic hepatitis)
  -  Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion
  -  Viral syndrome diagnosed during the two weeks before inclusion
  -  Chronic immunosuppressive therapy
  -  Known concurrent malignant hematologic or solid disease
  -  Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.
  -  Patients receiving full-dose anticoagulant / antiplatelet therapy
  -  Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

Summary: The purpose of this study is to determine the safety and tolerability of VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.

Detailed description: The study consists of three parts:
  -  Part I is a dose escalation study to determine the safety and tolerability of a single intravenous injection of VCN-01 alone
  -  In Part II the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine.
  -  In Part III the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine in a "delayed" schedule compared with Part II.

Eligibility: Inclusion Criteria:
  -  Male/Female patients aged 18 years or over
  -  Patients must provide written informed consent
  -  Part I: Patients with histologically confirmed, locally advanced or metastatic solid tumors. Part II and Part III: Patients with histologically confirmed, pancreatic adenocarcinoma for which the established therapy is Abraxane®/Gemcitabine (clinical standard of care)
  -  Life expectancy above 3 months
  -  Patients willing to comply with treatment follow-up
  -  ECOG Performance status 0 or 1
  -  Adequate baseline organ function (hematologic, liver, renal and nutritional)
  -  Use a reliable method of contraception in fertile men and women
  Exclusion Criteria:
  -  Active infection or other serious illness or autoimmune disease
  -  Treatment with live attenuated vaccines in the last three weeks
  -  Known chronic liver disease (liver cirrhosis, chronic hepatitis)
  -  Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion
  -  Viral syndrome diagnosed during the two weeks before inclusion
  -  Chronic immunosuppressive therapy
  -  Concurrent malignant hematologic or solid disease
  -  Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.
  -  Patients receiving full-dose anticoagulant / antiplatelet therapy
  -  Adequate levels of neutralizing antibodies against adenovirus
  -  Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer

Summary: This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  Subjects greater than or equal to (>=) 18 years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:
  -  Radiosensitizing doses of 5-fluorouracil;
  -  Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
  -  Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
  -  Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
  -  Subjects may have measurable or non-measurable disease according to RECIST 1.1.
  -  Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  -  Acceptable hematological status, liver and renal function as defined in the protocol
  -  Other protocol defined inclusion criteria could apply
  Exclusion Criteria:
  -  Significant cardiac or peripheral vascular arterial disease
  -  Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
  -  Severe chronic obstructive or other pulmonary disease with hypoxemia
  -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  -  Subjects receiving concomitant treatment with radiotherapy or other investigational drugs
  -  Other protocol defined exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes.

Summary: Epithelial Ovarian cancer (EOC) is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually.
  State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.
  In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.
  Aim of this study:
  There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.

Detailed description: Epithelial Ovarian cancer is the leading cause of death among gynaecologic malignancies in western civilized countries, with an estimated prevalence in Europe and the US of 752,600 in 2007 and 59,828 deaths annually. Treatment and survival of the patients depend primarily on the stage of the disease. Of all EOC patients only 25% are diagnosed at an early stage while the tumour is confined to the pelvis. In these cases the five-year survival rate is 80% to 90% and the disease can often be cured by the combination of surgery and chemotherapy. Unfortunately, almost 75% of women affected have advanced stage disease with metastatic spread throughout the abdominal cavity or to retroperitoneal lymph nodes at the time of diagnosis; five-year survival rates drop to 10%-30% for advanced disease, despite maximum surgical effort and combination chemotherapy.
  State-of-the-art diagnostic tests for EOC include transvaginal ultrasonography and serum cancer antigen (CA-125) measurements; the specificity of these diagnostic tools however is low, and both tests are not effective enough at detecting EOC early enough to improve clinical outcomes. Definitive diagnosis of EOC still relies on histological or cytological confirmation. These findings underline the importance for an effective test for early detection of EOC.
  In the current project we will obtain a lavage of the uterine cavity. It will be investigated whether cells from EOCs or genetic material from those cells can be detected in the lavage fluid.
  Aim of this study:
  There is a clear clinical need for a diagnosis test to detect EOC at an earlier stage.

Eligibility: Inclusion Criteria:
  -  suspected ovarian cancer
  -  verified ovarian cancer
  Exclusion Criteria:
  -  pregnant
  -  incapacitated persons

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: DCE MRI in Diagnosing Patients With Pancreatic Cancer

Summary: This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field and radio frequency pulses. These pictures may help identify underlying malignancy in patients at high risk or active malignancy in patients who have undergone chemotherapy for pancreatic cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Assess the ability of DCE MRI to identify the presence of pancreatic cancer in patients at high risk for hereditary pancreatic cancer.
  II. Assess the ability of DCE MRI to identify the presence of pancreatic cancer in patients with cystic lesions of the pancreas.
  III. Assess the ability to DCE MRI to accurately predict tumor margins in patients who have undergone chemotherapy for pancreatic cancer.
  SECONDARY OBJECTIVES:
  I. In each of the three groups listed above clinical factors associated with the presence of pancreatic cancer will be analyzed; in addition, disease free survival and overall survival will be analyzed in each group.
  OUTLINE: Patients are assigned to 1 of 3 groups.
  ARM I (High-risk for familial or hereditary pancreatic cancer): Patients undergo DCE MRI for up to 3 scans.
  ARM II (Intraductal Papillary Mucinous Neoplasms (IPMN)): Patients undergo DCE MRI prior to surgery.
  ARM III (Unresectable pancreatic cancer): Patients undergo DCE MRI before and after neoadjuvant therapy.

Eligibility: Inclusion Criteria:
  -  Must be consented for the Oregon Pancreatic Tumor Registry (OPTR)
  -  Must not have contraindication for MRI or intravenous (IV) contrast administration
  Exclusion Criteria:
  -  Allergy to intravenous contrast agents Prohance or Ferumoxytol

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.

Summary: Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. In most cases, invasive endoscopic explorations are necessary for histological diagnosis before deciding of the most appropriate treatment (palliative chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and 92% in situations where three different procedures are required. EUS-FNA has to be performed by a physician properly trained for this type of interventional endoscopy. Some severe complications may occur but are relatively rare in expert centers (bleeding, perforation, complications of general anesthesia ...).
  Diagnostic alternative approach is biological with research in the peripheral blood of markers of tumor disease. It is possible to detect indirect markers which are molecules produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor biological material (circulating tumor cells (CTCs) or circulating tumor DNA).
  The value of detection of CTCs is not determined for the diagnostic and therapeutic management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable forms.


Eligibility: Inclusion Criteria:
  -  Patient is male or female, and > 18 years of age
  -  Patient has a nonmetastatic solid pancreatic tumor (proved by CT thoraco-abdomino-pelvic) without histological evidence
  -  Patient is referred for surgical treatment or biliopancreatic endoscopic ultrasound with fine needle aspiration (EUS-FNA) of a pancreatic mass
  -  Patient has agree to participate by giving written informed consent
  Exclusion Criteria:
  -  metastatic pancreatic tumor
  -  cancer or other hematologic malignancy during treatment or in remission for less than 5 years.
  -  minor patient under 18 years
  -  contraindication to surgical treatment or contraindication to the biliopancreatic EUS-FNA
  -  patient under guardianship
  -  Pregnant or lactating women

Relevance to patient case: definitely relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis

Summary: The purpose of this study is to compare the diagnostic gain between 22G standard needle vs 19G Flex needles transduodenal punctures of masses of the pancreatic head.

Detailed description: The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic masses is about 70 - 80 % with the 22G standard needle. Pancreatic adenocarcinoma is known to have a severe prognosis and a low rate of survival even after curative surgery. The study of pancreatic solid tumors is one the main diagnostic problem present in the investigators daily practice. In most of non operated patients, EUS-FNA is the sole possibility to confirm the diagnosis of malignancy which is required to initiate chemotherapy and/or radiotherapy. To improve the performances of the EUS-FNA, new needles are now disposable either with a cutting window design (EchoTip ProCore-COOK Medical) or flexible 19G needle (19G Expect Flex - Boston-Scientific). The goal is to obtain more tissue material with the possibility of a histologic study without increasing the risk of the puncture which is very low (complications rate < 1%). The problem concerns the lesion of the head of the pancreas requiring a trans-duodenal access for the puncture . In this position, the needle is very difficult to push out the operator channel and, in some cases, the puncture is quite impossible with stiff needles as "ProCore" or standard 19G. Thus, the interest of flexible 19G needle is to be used in difficult technical cases as transduodenal access for head pancreatic tumors, with a good safety and more efficacy than 22G needles.

Eligibility: Inclusion Criteria:
  solid tumor of pancreas to receive a biopsy under endoscopic ultrasound (EUS) patient understands the study procedures, risks and voluntarily agrees to participate by giving written informed consent
  Exclusion Criteria:
  patient participates in an other study patient mentally or legally incapacitated contraindications to the achievement of upper gastrointestinal endoscopy haemorrhagic disease, disorder of hemostasis and coagulation (TP<60%, TCA>40sec and platelets <60000/mm3) patient with anticoagulant or antiaggregating treatment that could not be stopped for the endoscopic procedure pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging) pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Pancreatic Stump Closure After Distal Pancreatic Resection

Summary: The aim of this study is to investigate whether finnish binding pancreatico-jejunal anastomosis is feasible and prevents the risk for post operative pancreatic fistula after distal pancreeatectomy.


Eligibility: Inclusion Criteria:
  -  patiens which the distal pancreatic resektions
  -  the type of resections that is techically possible with finnish binding panceatico-jejunal anastomosis
  Exclusion Criteria:
  -  if the pancreas is not suitable for this kind of anastomosis

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

Summary: The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic Adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  1. Subjects with histological or cytological evidence of metastatic Pancreatic Adenocarcinoma, Measurable disease or non-measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version criteria
  -  2. Subjects with a life expectancy of at least 12 weeks,
  -  3. Subjects with an Eastern cooperative oncology group performance status (ECOG PS) of 0, 1 or 2,
  -  4. Subjects with the following adequate organ functions:
  -  White blood cell count ≥3,000/μL (or absolute neutrophil count ≥1,500/μL) and ≤ 12,000/μL ,
  -  Platelet count ≥100.0 × 10^9/L,
  -  Hemoglobin ≥9.0 g/dL,
  -  Serum creatinine ≤1.5 × the upper limit normal (ULN),
  -  Total bilirubin ≤2.0 × ULN,
  -  Serum aspartate transaminase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases), and
  -  Serum alanine aminotransferase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases).
  Exclusion Criteria:
  -  Subjects received the following previous therapies for Pancreatic Adenocarcinoma:
  -  Surgery within the 4 weeks prior to randomization,
  -  Radiation and chemoradiation within the 12 weeks prior to randomization,
  -  Radiation for pain relief within the 4 weeks prior to randomization,
  -  Gemcitabine used as a neoadjuvant or an adjuvant on surgery within the 24 weeks prior to randomization,
  -  Chemotherapy except GEM used as an adjuvant on surgery within the 4 weeks prior to randomization,
  -  Gemcitabine ≥600 mg/m^2 as sensitizer for chemoradiation,
  -  Gemcitabine <600 mg/m^2 as sensitizer for chemoradiation within the 12 weeks prior to randomization,
  -  Gemcitabine used for systemic chemotherapy, or
  -  Systemic chemotherapies except GEM within the 4 weeks prior to randomization.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Summary: This study aim to investigate Changes in tumor tissue and serum biomarkers before and after cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers to predict and evaluate the patients who will be benefit from cetuximab combined with preoperative radiotherapy.


Eligibility: Inclusion Criteria:
  (1)18 to 65 years old,male or female (2)Pathologically or cytologically proven thoracic middle-lower esophageal squamous cell carcinoma; (3)clinical stage II or stage III; (4)Primary tumors can be measured; (5)Karnofsky score >70; (6)Estimated life expectancy of at least 12 weeks; (7)reproductive age women should ensure that before entering the study period contraception; (8)Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³; (9)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal; (10)Creatinine normal OR creatinine clearance ≥ 60 mL/min; (11)Patients have good compliance to treatment and follow-up of acceptance; (12)Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value; (13)Considered operable (i.e. appropriate organ functions and ability to undergo general anesthesia); (14)No severe or uncontrolled cardiovascular disease; (15)No active uncontrolled infection;
  Exclusion Criteria:
  1. Patient who have distant metastasis
  2. The primary tumor or lymph node already received surgical treatment (except for biopsy);
  3. Patient who received radiotherapy for primary tumor or lymph node;
  4. Patient who received the the epidermal growth factor targeted therapy;
  5. Patient who received chemotherapy or immunotherapy;
  6. Patient who suffered from other malignant tumor;
  7. Epidermal growth factor receptor（EGFR）mutation（-）;
  8. Patient who have taken other drug test within 1 month;
  9. Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
  10. Subject with a severe allergic history or idiosyncratic;
  11. Subject with severe pulmonary and cardiopathic disease history; Refuse or incapable to sign the informed consent form of participating this trial;
  12. Drug abuse or alcohol addicted;
  13. Subject with a Personality or psychiatric diseases, people with no legal; capacity or people with limited capacity for civil conduct;

Relevance to patient case: not relevant