araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: OSI-906 With Gemcitabine and Erlotinib for Metastatic Ductal Adenocarcinoma of the Pancreas

Summary: OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been used in other research studies and information from those suggests that OSI-906 may help block cell receptors involved in tumor growth.
  Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this research study, the investigators are looking for the highest dose of OSI-906 that can be given safely in combination with gemcitabine and erlotinib. This dose will then be given together with gemcitabine and erlotinib to a further group of patients with pancreatic cancer.

Detailed description: This study will be conducted in two parts: a phase I study and a phase II study. In both instances, a treatment cycle is 28 days (4 weeks). Subjects will take OSI-906 by mouth, twice a day, every day. Subjects will receive gemcitabine through an IV in clinic over 30 minutes on days 1, 8 and 15 of each 28-day cycle. Subjects will take erlotinib by mouth, once a day, every day.
  At every visit subjects will have a physical exam and blood tests. An EKG will be done on days 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. A CT scan will be done every 2 cycles (8 weeks).
  Subjects will complete a daily drug diary and perform glucose monitoring (finger stick) once daily at home.

Eligibility: Inclusion Criteria:
  -  Metastatic pancreatic ductal adenocarcinoma
  -  Measurable disease
  -  Life expectancy > 12 weeks
  -  Normal organ and marrow function
  -  Fasting blood glucose </= 150 mg/dL
  -  Able to swallow pills
  Exclusion Criteria:
  -  Prior chemotherapy or radiotherapy for treatment of pancreatic cancer
  -  Receiving any other experimental agent
  -  Known brain metastases
  -  History of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine, erlotinib, or OSI-906
  -  Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea)
  -  Use of enzyme-inducing anti-epileptic drugs
  -  Diabetes mellitus which requires the use of exogenous insulin for glucose control
  -  Major surgery within 4 weeks of the start of study treatment
  -  Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  -  Use of strong or moderate CYP1A2 inhibitors/inducers
  -  Pregnant or breast feeding
  -  History of a different malignancy unless disease-free for at least 3 years
  -  HIV positive

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: EUS Guided Celiac Neurolysis

Summary: -  Hypothesis:
  - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
  -  Rationale:
  -  Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.


Eligibility: Inclusion Criteria:
  -  1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
  -  2. Cytologic or histologic confirmation of pancreatic carcinoma
  -  3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
  -  4. EUS clinically indicated (for non-study purposes)
  Exclusion Criteria:
  -  1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
  -  2. Abdominal surgery within 1 month
  -  3. Prior celiac plexus or ganglia neurolysis.
  -  4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
  -  5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

Summary: The purpose of the study is to determine the safety of radiofrequency ablation of locally advanced pancreatic cancer that can not be surgically removed with the current standard procedures. Complications after the operation will be registered. Moreover a pain score will be determined, length of hospital stay, chemotherapy, survival, progression free survival and a tumour marker.

Detailed description: Pancreatic cancer is the fourth leading cause of cancer related death in the Western world. At time of diagnosis, 20% of patients present with a resectable tumour, 40% with an irresectable locally advanced tumour (without metastases) and 40% with metastatic disease. The median survival of patients with irresectable locally advanced pancreatic cancer is only 6 months. Currently, there is no effective treatment for these patients. Therefore, there is an urgent need for new therapies. Radiofrequency ablation (RFA) is a technique that has been demonstrated to be effective in the treatment of several irresectable tumours. RFA produces local tumour destruction through high frequency alternating current flowing from an electrode implanted directly into the tumour and causing frictional heating. The purpose of this study is to determine the safety of RFA-pancreas in patients with non-metastasized, irresectable, locally advanced pancreatic cancer.

Eligibility: Inclusion Criteria:
  1. Patients with irresectable locally advanced pancreatic cancer found at laparotomy with histologic diagnosis before start of RFA
  2. Patient considered eligible to undergo pancreatic surgery as assessed by the general criteria of the departments of anaesthesiology and surgery of the UMC Utrecht
  3. Fully informed written consent given
  Exclusion Criteria:
  1. Patients younger than 18 years
  2. Pregnancy
  3. Patients with distant metastases
  4. Portal vein thrombosis seen on CT preoperatively

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: The Diagnostic Technology Applied Research of CDK5RAP2 in Breast Cancer

Summary: Selected 400 cases of women with primary breast cancer who were treated with operation randomly, then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Detailed description: The investigators selected 400 cases of women with primary breast cancer who were treated with operation randomly,then detect the expression of CDK5RAP2 of cancer tissue. At the same time randomly selected 100 women with primary breast cancer who were under neoadjuvant chemotherapy. Detect the expression of CDK5RAP2 before and after neoadjuvant chemotherapy.

Eligibility: Inclusion Criteria:
  1. Provision of informed consent
  2. Pathological confirmation of breast cancer
  3. Tumor stage(TNM):T2-4bN0-3M0
  4. ER(+) and/or PR(+).
  5. Premenopausal woman.
  6. Age≥40 years
  7. Measurable disease as per RECIST criteria
  8. Karnofsky≥70
  9. Laboratory criteria:
  -  PLT≥100*109/L
  -  WBC≥4000/mm3
  -  HGB≥10g/dl
  -  ALT and AST<2*ULN
  Exclusion Criteria:
  1. Presence of metastatic disease.
  2. Inflammatory breast cancer.
  3. Bilateral breast cancer.
  4. previous chemotherapy or hormonal therapy for current breast neoplasm.
  5. other malignant tumor (concurrent or previous).
  6. Pregnant woman.
  7. Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
  8. Any severe systemic disease contraindicating chemotherapy.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Study of 124I-NM404 in Advanced Solid Malignancies

Summary: The purpose of this study is to assess the use of investigational compound 124I-NM404 for accurate detection and characterization of a wide variety of solid primary and metastatic malignancies anywhere in the body.

Detailed description: 124I-NM404 is a new investigational agent being developed to better identify local tumors and cancerous tumors using imaging technologies such as positron emission tomography (PET) scans. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. 124I-NM404 is only taken up by the cancer cells, not the normal cells. Compared to traditional methods such as CT (computed tomography) or MRI (Magnetic resonance imaging), 124I-NM404 may help physicians more accurately see and evaluate cancerous tumors. This agent has been safely studied in animals and a limited number of human patients with lung cancer. This study is being done to determine the best dose to use and to fully evaluate the images that result from using this new agent.

Eligibility: Inclusion Criteria:
  -  Diagnosis of advanced solid malignancy.
  -  Allowed tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer
  -  Disease must be at least 1cm in diameter
  -  Brain metastasis must be stable for at least one month.
  -  ECOG performance status 0-2
  -  Anticipated survival less than 5 years, as per the treating physician
  Exclusion Criteria:
  -  Skin lesions only
  -  Chemotherapy or radiotherapy within 1 week
  -  Residual toxicities of grade 2 or greater from prior therapy
  -  Adequate organ function as per specified laboratory parameter
  -  Platelet count > or = to 75,000/uL

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Biomarkers Study in Pancreatic Cancer

Summary: Study Design:
  Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for pancreatic cancer; (3) willing to sign informed consent.
  The pancreatic tumor, tissue specimen and blood sample before or after treatment will be collected from department of pathology, surgery or diagnostic medicine.

Detailed description: We expect to collect tissue samples from 270 pancreatic cancer patients of any stages. Since the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a year. The patient enrollment will be completed in 4 years. Clinical follow-up will be completed in another one year. Data analysis and correlation study may be finished in the end of 5th year of this study.

Eligibility: Inclusion Criteria:
  1. Patients enrolled to TCOG 3207 study: A Randomized Phase III Study of Adjuvant Gemcitabine versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection.
  2. Patients who were not eligible for TCOG 3207 study but received surgery or biopsy for pancreatic cancer.
  3. Patients have to sign informed consent for tissue specimen collection, according to the regulation of DOH.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers

Summary: Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are mostly diagnosed only at later stages of the disease's course through histoimmune staining and molecular biology processes on the tissues biopsied from the gastrointestinal system under invasive diagnostic procedures of colonoscopy.
  Oral fluid presents a large protein complexity and has been recently used as a diagnostic biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal cancers. Proteomic technologies provide the tools needed to discover and identify disease-associated biomarkers.
  The aim of the present study is to identify salivary bio-markers in patients suffering from colorectal cancers.


Eligibility: Inclusion Criteria:
  -  Has not yet started treatment for the identified cancer
  Exclusion Criteria:
  -  medically compromised patients
  -  congenital syndromes
  -  being treated with radiotherapy or chemotherapy.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Summary: Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.

Detailed description: Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.

Eligibility: Inclusion Criteria:
  -  Patients scheduled for elective pancreaticoduodenectomy
  -  Pancreatic gland with high risk criteria for associated postoperative morbidity
  Exclusion Criteria:
  -  Patients do not accept participation
  -  Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia

Summary: 1.1 Primary Objectives
  -  To determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (MDS), including primary refractory disease
  -  To determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts
  -  To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential combination with ara-C and Mitoxantrone
  -  To determine if the timed sequential combination of PD 0332991 with ara-C and mitoxantrone can induce clinical responses in adults with relapsed or refractory acute leukemias and high-risk MDS
  1.2 Secondary Objectives:
  -  To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell populations in vivo
  -  To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest malignant cells in the G 1 phase of cell cycle, followed by synchronized release of those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C cytotoxicity


Eligibility: Inclusion Criteria:
  -  Adults age ≥ 18 years
  -  Multilineage bone marrow failure
  -  Serum creatinine ≤ 2.0 mg/dl
  -  Hepatic enzymes (AST, ALT) ≤ 3x upper limit of normal (ULN)
  -  Bilirubin ≤ 2.0 mg/dl, unless due to Gilbert's disease, hemolysis or leukemic infiltration
  -  Left ventricular ejection fraction ≥ 45%
  -  QTc ≤ 470 msec
  -  RB expression is required for the action of PD 0332991. Because rb deletions and mutations are rare in acute leukemias and MDS, screening for RB expression will not be required before enrollment. Pretreatment biopsies will be stored and analyzed for RB expression if needed subsequently.
  Exclusion Criteria:
  -  • No more than 5 cytotoxic regimens
  -  Previous allogeneic or autologous stem cell transplantation permitted
  -  ≥ 3 weeks delay from prior cytotoxic chemotherapy or radiation therapy
  -  ≥ 2 week delay from prior biologic therapies including hematopoietic growth factors and vidaza or decitabine
  -  If using Hydroxyurea, steroids, tyrosine kinase/src kinase inhibitors, arsenic, interferon for count control, must be off therapy for ≥ 48 hours prior to beginning PD 0332991
  -  No concomitant use of potent CYP450 3A4 inhibitors (e.g. triazole antifungal agents) or inducers (e.g. omperazole, dilantin, dexamethasone) within 7 days prior to beginning PD 0332991

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Role of Perfusion CT in Pancreatic Cancer

Summary: The purpose of this study is
  1. to determine whether the perfusion parameters in the normal pancreas and the pancreas cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT
  2. to determine whether initial perfusion parameters as well as perfusion parameter change in pancreas adenocarcinoma before and after chemotherapy are different between chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD, PD according to RECIST 1.1).

Detailed description: 1. Performance of preoperative perfusion CT for preoperative staging is assessed by comparing with operative finding and histologic disease staging
  2. Estimation of initial or change of pancreas cancer perfusion parameters and whether those can provide cut-off value for predicting response of chemotherapy in patients with pancreas adenocarcinoma

Eligibility: Inclusion Criteria:
  -  patients who are older than eighteen years
  -  patients in whom operation and preoperative computed tomography are scheduled for resectable pancreas adenocarcinoma or pancreas neuroendocrine tumor
  -  patients in whom chemotherapy is scheduled for histologically confirmed pancreas adenocarcinoma
  -  patients in whom chemotherapy is planned for highly suspicious pancreas adenocarcinoma on imaging workup
  -  patients who agree with the study and whose informed consent is obtained.
  Exclusion Criteria:
  -  patients who are younger than eighteen years old
  -  patients in whom previously radiation therapy was performed and the RTx field includes pancreas
  -  patients with recurred pancreas adenocarcinoma
  -  patient who are pregnant or nursing patients
  -  patients with renal failure (GFR<30mL/min)
  -  patients with history of malignancy, except malignancy is in complete remission after operation or iodine therapy for at least five years)
  -  patients with hypersensitivity for iodine or contrast media or other causes of contraindication of contrast-media enhanced CT scan
  -  Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completion of the study.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence

Summary: The primary objective is to develop a rapid in vitro screening assay for detection of pancreatic cancer biomarkers in blood of patients with pancreatic cancer.

Detailed description: The goal of the project is to develop a rapid in vitro screening assay for detection of cancer biomarkers in blood. The aim is testing and optimization of nanoparticle sensors, based on cyanine dyes that are chemically linked to Fe/Fe3O4 nanoparticles via protease-selective consensus (cleavage) sequences. The focus is on the quantitative determination of active cancer-specific proteases in blood via simple fluorescence measurements. The matrix metalloproteinases, urokinase-type plasminogen activator, and cathepsins, are up-regulated in the vast majority of progressing cancers and can, therefore, serve as markers for cell survival/tumor progression, angiogenesis, and tissue remodeling/invasion

Eligibility: Inclusion Criteria:
  Inclusion Criteria for Pancreatic Cancer Patients:
  -  Patients will either have a histologic diagnosis of pancreatic carcinoma or a clinical picture consistent with pancreatic cancer and will be undergoing surgery or a diagnostic procedure to confirm the diagnosis.
  -  Patients will have had no prior treatment or surgery
  Inclusion Criteria for Healthy Subjects:
  -  Subjects will have no prior history of any cancer
  Exclusion Criteria:
  Exclusion Criteria for Pancreatic Cancer Patients
  -  Any prior treatment for pancreatic cancer
  -  Poorly controlled diabetes
  Exclusion Criteria for Healthy Subjects
  -  Poorly controlled diabetes

Relevance to patient case: not relevant