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

Clinical trial: PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer

Summary: Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?

Detailed description: Randomized, double-blind clinical trial aiming to assess the impact of pancreas enzyme replacement therapy in weight loss and quality of life.
  Prevalence of pancreatic exocrine insufficiency (PEI) will be determined with fecal elastase-1 test (FE1) in patients with unresectable pancreatic cancer, without evidence of pancreatic duct (PD) or common bile duct (CBD) obstruction based on MRI or / and endoscopic ultrasound (EUS).
  Patients with PEI (FE1 <200) receive Pertzye or placebo in a cross-over fashion, each for 4 weeks.
  Body weight, body mass index (BMI), body composition (Bioimpedance), are measured at the time of diagnosis of PEI and at 4 and 10 weeks of cross-over treatment. Baseline measurement of Vitamin D-25, Vitamin A, iron (ferritin, total iron binding capacity (TIBC), iron), Vitamin B12,Tissue transglutaminase IgA (tTG) with total Immunoglobulin A (IgA).
  Quality of Life (pain, diarrhea, weight, bloating, etc.) assessed at 0,4,10 weeks with the Functional Assessment of Cancer Therapy for patients with liver, bile duct and pancreas cancer (FACT-Hep) for physical, social, emotional, and functional quality of life.

Eligibility: Inclusion Criteria:
  -  Patients 18-80 years
  -  Underlying pancreatic adenocarcinoma, unresectable (local invasion or distant metastasis)
  -  On established chemotherapy regimen for pancreas cancer, which will be continued over the time of study
  -  Fecal elastase-1 test (FE1) less than 200 mcg pancreatic elastase/g stool
  Exclusion Criteria:
  -  Common bile duct obstruction resulting in obstructive jaundice
  -  Celiac disease
  -  Crohn's disease
  -  Benign pancreatic conditions
  -  Bowel obstruction
  -  Surgically altered bowel anatomy

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

Clinical trial: Registry for Pancreatic Cancer

Summary: This is an observational, prospective and retrospective registry of patients with pancreatic cancer treated in Duke University Health System, which will examine patient and treatment effects on cancer outcomes.


Eligibility: Inclusion Criteria:
  -  Pancreatic cancer
  Exclusion Criteria:
  -  Younger than 18 years of age

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

Clinical trial: Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy

Summary: The purpose of this study is to determine the interrelationship between cachexia, neural invasion and diabetes in patients with pancreatic cancer. Thus the investigators propose to identify the protein expression levels of Activin and Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.

Detailed description: In this study, the investigators will prospectively evaluate pancreatic adenocarcinoma patients with or without cachexia, perineural invasion and diabetes.
  Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis and blood samples are drawn.
  Thus the investigators propose to identify the protein expression levels of Activin and Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with benign pancreatic disorders and healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.
  Furthermore, the investigators propose to identify the prognostic role of these biomarkers in the development of metastasis and survival in patients with adenocarcinoma, with and without diabetes and cachexia; to identify a new biomarker predictive of cachexia and eventually to select patients likely to benefit from treatment with antagonists of activin (or hypoglycemic treatment) and investigating the role of invasion neural in the appearance of cachexia in patients with pancreatic adenocarcinoma.
  Follow-up: with phone-calls on an every 6 month, for up to 2 years, retaining the following data: survival, date of decease and its direct cause, the presence of tumor recurrence.

Eligibility: Inclusion Criteria:
  1. Age over 18 years old
  2. EUS or surgery biopsy confirming the diagnosis of adenocarcinoma
  3. Informed consent
  Exclusion Criteria:
  1. obvious malabsorption
  2. artificial nutrition
  3. hyperthyroidism
  4. major depression
  5. other causes of malnutrition
  6. refusing to enter 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: A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib

Summary: This study will allow for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.

Detailed description: This protocol is a sub-protocol of an interventional study. Because the main study is interventional, this study was approved by FDA as an interventional study. It cannot stand alone without the parent study. The sites will receive diagnostic information for all patients that come on study.

Eligibility: Inclusion Criteria:
  -  Written informed consent must be obtained prior to any baseline/screening procedures.
  -  Patients eligible for this companion sample collection protocol sample collection protocol must meet all inclusion in CLEE011A2404.
  Exclusion Criteria:
  -  Patients eligible for this companion sample collection protocol must not meet any of the exclusion criteria in the CLEE011A2404 study, in addition to the following:
  -  Patients without either fresh or archival tumor tissue accessible.

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

Clinical trial: Efficacy and Safety of Treatment With Alpelisib Plus Endocrine Therapy in Patients With HR+, HER2-negative aBC, With PIK3CA Mutations, Whose Disease Has Progressed on or After CDK 4/6 Treatment With an Aromatase Inhibitor (AI) or Fulvestrant

Summary: Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2-negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6 treatment with an aromatase inhibitor (AI) or fulvestrant


Eligibility: Inclusion Criteria:
  -  patient is male or female 18 years or older
  -  Patient is identified PIK3CA mutant status
  -  Patient has confirmed HER2-negative advanced breast cancer (aBC)
  -  Patient must be diagnosed with aBC with documented progression on or after CDK 4/6 treatment (adjuvant or metastatic setting)
  -  Patient has histological and/or cytological confirmed ER+ and/or PgR+ aBC
  -  Patient has either measurable disease per RECIST v1.1 or at least one predominantly lytic bone lesion must be present
  -  ECOG function of greater or equal to 2
  -  Patient has adequate bone marrow function
  -  Patient has adequate liver and renal function
  Exclusion Criteria:
  -  patient has received prior treatment with any PI3K inhibitors
  -  patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
  -  Patient has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanoma skin cancer or curatively resected cervical cancer
  -  Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to enrollment, and who has not recovered to grade 1 or better from related side effects of such therapy
  -  History of acute pancreatitis within 1 year of screening or past medical history of pancreatitis
  -  Bilateral diffuse lymphangitis carcinomatosis
  -  Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
  -  At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment
  -  Clinically stable CNS tumor at the time of screening untreated or without evidence of progressions for at least 4 weeks after treatment as determined by clinical examination and brain imaging (MRI or CT) during screening period and stable low dose of steroids for 2 weeks prior to initiating study treatment
  -  Patient with severe liver impairment (Child Pugh score B/C
  -  Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
  -  Patient has documented pneumonitis which is active and requiring treatment

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 Research on 89Zr-ABT806 PET Imaging in High Grade Glioma

Summary: The epidermal growth factor receptor variant Ⅲ(EGFR vⅢ) is commonly detected in high-grade gliomas, which is also an important epitope in EGFR-targeted therapies and correlated to poor prognosis. However, detection of this mutant usually needs resected tumor samples. For biopsy samples, test results may not represent the EGFR vⅢ status of the whole tumor tissues because of the heterogeneity of tumor. It is also not applicable for patients who are not suitable for surgical procedure due to the tumor location or patients' general conditions. Because of the importance of the epidermal growth factor receptor (EGFR) signal pathway in oncogenesis, maintenance, and progression of high grade glioma, there has been an intense effort to develop noninvasive molecular imaging approach for the selection and monitoring of EGFR-targeted therapies.
  Based on investigators' previous study, investigators plan to perform PET scanning on the participants with high grade gliomas after the injection of the second generation of EGFR tracer ,89Zr-ABT806, which can be specifically binded to EGFR vⅢ . After fusing the PET and MRI images, investigators precisely obtain the tissue from the"hot-spot" on the PET image through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status will be detected by molecular methods to analyze the correlation with the 89Zr-ABT806 PET image qualitatively and quantitatively. Investigators' final goal is to detect EGFR vⅢ by noninvasive molecular imaging procedure for the clinical outcome prediction and the selection of EGFR-targeted therapies.


Eligibility: Inclusion Criteria:
  1. Clinical manifestations and imaging examination (CT, MRI, et al) are in accordance with high grade glioma
  2. No PET/CT scanning contraindications
  3. No MRI scanning contraindications
  4. Patients older than 18 years old
  5. ECOG score between 0 to 2
  6. Patients with sufficient bone marrow, kidney and liver function reserve.
  7. All patients gave written informed consent.
  Exclusion Criteria:
  1. Patient who has received immune therapy, radiation therapy, chemotherapy, hormone drugs, biological products or other clinical trials within 14 days.
  2. Patient who has received EGFR monoclonal antibody therapy within 4 weeks.
  3. Patients who has not fully recovered form the past drug toxicity reaction (CTCAE in grade 2 or above).
  4. Patient who has received major surgery within 7 days.
  5. Patients with allergies to immunoglobulin.
  6. Breastfeeding women.
  7. pregnant women
  8. Patients with severe clinical condition.
  9. Inability to give informed consent

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

Clinical trial: Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy

Summary: This research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations

Detailed description: This research is being done to identify which pancreatic cancer patients should undergo genetic evaluation. A patient's personal and family history of cancer is the information typically used to make this decision, but there are currently no accurate, evidence-based guidelines that exist to help doctors use this information to make a decision.
  The investigators hope that by testing all new pancreatic cancer patients, they can determine which clinical factors predict for genetic mutations in order to create a risk assessment tool.
  The investigators want to determine which patients with pancreatic cancer will benefit from genetic testing. To do so, the investigators will offer all patients with pancreatic cancer in the Dana-Farber Gastrointestinal Oncology clinic referral for genetic evaluation. At the Cancer Genetics and Prevention clinic appointment, the provider will review the patient's personal and familial history of cancer and offer genetic testing.

Eligibility: Inclusion Criteria:
  -  Diagnosis of pancreatic ductal adenocarcinoma
  -  Signed initial informed consent
  -  Participant agrees to genetic counseling
  Exclusion Criteria:
  -  Prospective participant unable to sign informed consent based on referring physician recommendation.
  -  Patient has neuroendocrine pancreatic tumor

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

Clinical trial: Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer

Summary: Patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and decreased quality of life. The patients also often need pancreatic enzyme supplements. In this prospective study the aim is to see whether patients undergoing palliative pancreatic duct drainage will experience less chronic abdominal pain and a higher quality of life than patients with the same diagnosis without the procedure. The study also investigates whether the nutritional state of the patients with palliative stents remains better than in the control group.

Detailed description: In this prospective study all patients have inoperable pancreatic cancer. In these patients the pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm. Patients also suffer from chronic abdominal pain caused by pancreatic cancer. The strength of the pain the patients are experiencing is evaluated with visual analogue scale (VAS). Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 6 at the time of recruitment.
  In this pilot study a total of 40 patients are recruited. Patients are divided into to two 20 patient groups. First group will receive a pancreatic duct stent followed by pain medication if needed and the control group will go with conventional pain relief methods only. All patients are asked to evaluate the strength of experienced pain with visual analogue scale at the time of recruitment, and then every 4 weeks up to 24 weeks. The patients will also be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 quality of life questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks. The patients are also asked to report their body weight, and the amount of pancreatic enzyme supplements needed at every point of survey.

Eligibility: Inclusion Criteria:
  -  Patients have inoperable pancreatic cancer.
  -  Pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm.
  -  Patients in this study report experiencing chronic abdominal pain at least the strength of VAS 6 (Visual Analogue Scale) at the time of recruitment.
  Exclusion Criteria:
  -  Patients are not fit enough to undergo ERCP

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 Role of ctDNA, PVT1 and ROS in Diagnosis and Treatment of Gastrointestinal and Hepatobiliary Pancreatic Cancer

Summary: This study aims to evaluate the role of ct-DNA, PVT1 and reactive oxygen species (ROS) as biomarkers in the diagnosis, treatment and recurrence monitoring of gastrointestinal and hepatobiliary pancreatic cancer.

Detailed description: Epidemiological surveys showed a significant increasing trend of gastrointestinal and hepatobiliary pancreatic cancer in recent years. How can make an early diagnosis of gastrointestinal and liver cancer as well as prognostic evaluation and efficacy monitoring, has become the hotspot. "liquid biopsy", which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.
  ct-DNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the ct-DNA originates from tumoral tissue. Besides, ct-DNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer.
  It is known that levels of cellular ROS correlate with the aggressiveness of tumour cells and prognosis of patients. Cancer cells with increased endogenous ROS stress are more sensitive to anticancer agents and high levels of ROS generated by chemotherapeutic agents can induce cell death. Hence, ROS levels before and after chemotherapy in cancer cells can be an early indicator of treatment efficacy, which has the potential to shed new light on the choice of cancer therapy.
  This study aims to evaluate the role of ct-DNA and ROS as biomarkers in the diagnosis, treatment and recurrence monitoring of gastrointestinal and hepatobiliary pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Patients with suspected of gastrointestinal and hepatobiliary pancreatic cancer
  -  Age from 18 - 80 years
  -  No serious organic and mental illness;
  Exclusion Criteria:
  -  Pregnancy
  -  No pathologic result
  -  Suffering other malignancies at the same time.

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

Clinical trial: Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification

Summary: [Study Design] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.
  [Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy


Eligibility: [Inclusion Criteria]
  -  Provision of informed consent prior to any study specific procedures
  -  Men and women aged at least 18 years
  -  Small cell lung cancer harboring RICTOR amplification
  -  Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no deterioration over the previous 2 weeks
  -  Minimum life expectancy of 12 weeks
  -  Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below:
  -  At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits.
  -  No history of non-autologous bone marrow transplant.
  Exclusion Criteria:
  -  Participation in another clinical study with an investigational product during the last 21 days.
  -  Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
  -  Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
  -  Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
  -  Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
  -  Any haemopoietic growth factors within 14 days prior to receiving study treatment.
  -  Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
  -  Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.

Relevance to patient case: not relevant