araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer

Summary: This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.


Eligibility: Inclusion Criteria:
  1. Known BRCA1 or BRCA2, TP53, PALB2 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high PRS.
  2. With life time risk of 40% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors.
  3. Without prior breast cancer.
  4. Must be older than 21 years.
  5. Willing to travel to University of Chicago Medical Center for imaging studies as well as any necessary follow-up procedures.
  6. Be able to give informed consent.
  Exclusion Criteria
  1. Active cancer at the time of enrollment.
  2. Current pregnancy or plans for pregnancy within two years of enrollment.
  3. Presence of a pacemaker or any other metallic foreign objects in their body that interferes with an MRI.
  4. Breast surgery within two weeks of study entry.
  5. History of kidney disease or abnormal kidney function.
  -  Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors or participating in a chemoprevention trial.

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer

Summary: The aim of the multi-centre study is to evaluate correctly the impact of three dimensional visualization on operation strategy and complications for Pancreatic Cancer.

Detailed description: Because of the complexity of Pancreatic Cancer, the limitations of 2D images of CT/MRI and the uncertainty of surgeons'experience, it is difficult for the surgeons to diagnosis and assess the operation strategy accurately based on traditional 2D imaging(CT/MRI).The aim of the multi-centre study is to evaluate correctly the impact of three-dimensional visualization on operation strategy and complications for Pancreatic Cancer.

Eligibility: Inclusion Criteria:
  1.18 years≤ Age ≤70 years 2.Compling with the diagnosis criteria of Pancreatic Cancer. 3.Primary Pancreatic Cancer without metastasis. 4.The patients are volunteered for the study.
  Exclusion Criteria:
  1. Patients with mental illness.
  2. Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
  3. The patients refused to take part in the study.
  4. There are other co-existed malignant tumors.

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Greater Omentum Binding to the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

Summary: Background and aim: Distal pancreatectomy (DP) is often performed for primary benign or malignant lesions occurred in the body or tail of the pancreas. The occurrence of pancreatic fistula (PF) after DP remains high, ranging from 5% to 60%, despite in high-volume centers. Management of pancreatic stump to prevent PF has been a long-standing issue in pancreatic surgery. Our group has proposed greater omentum binding as a novel approach to secure pancreatic stump with the purpose of reducing PF. With respect to the previous preliminary data which demonstrated greater omentum binding of pancreatic stump significantly reduced the occurrence of PF based on a small prospective cohort, we therefore aimed to verify the safety and effectiveness of this novel approach in a large prospective randomized cohort.
  Method: TJBDPS06 is a prospective, randomized controlled, parallel-group, superiority trial in a single high-volume pancreatic center. A total of 200 patients who will receive DP and fulfill the inclusion criteria will be randomly allocated to the greater omentum binding group or the group without this step in an enhanced recovery after surgery (ERAS) setting. The trial hypothesize that greater omentum binding of pancreatic stump could safely and effectively secure pancreatic stump following DP, therefore reducing the occurrence of PF. The primary outcome is PF within 90 days after DP. The secondary outcomes are overall morbidly, mortality, and major complications (Clavien-Dindo ≥III) within 90 days following DP. The duration of entire trial is presumably three years, including prearrangement, two-year inclusion period, and data analysis.
  Discussion: The current trial will be the first in demonstrating safety and effectiveness of greater omentum binding of pancreatic stump following DP in a large high-volume pancreatic center. This approach will offer an inexpensive, technically easy, and secure coverage technique for the pancreatic stump in DP and may be particularly useful for patients with a soft pancreas which is a markedly risk factor of PF.


Eligibility: Inclusion Criteria:
  -  All patients who undergo DP whether made by open or laparoscopic surgery;
  -  Patients age 18 to 75 years;
  -  Patients benefit from distal pancreatectomy according to NCCN guidelines;
  -  The subject understands the nature of this trial and willing to comply, and ability to provide written informed consent.
  Exclusion Criteria:
  -  Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs;
  -  History of abdominal disease or surgery which may results in obvious omentum adhesion;
  -  Synchronous malignancy in other organs;
  -  Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4;
  -  Pregnant women.

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Laparoscopic vs Open Pancreatectomy for Body and Tail Pancreatic Cancer

Summary: Open distal pancreatectomy (ODP) has been commonly employed for the treatment of a variety of cancers in body and tail of pancreas. Although many general surgical procedures have been increasingly performed laparoscopically or with laparoscopic assistance, until the current decade, laparoscopic pancreatic surgery had not been performed for its complicated anatomy. But laparoscopic distal pancreatectomy (LDP) has been widely accepted as a standard treatment for body and tail pancreatic cancer because there is no anastomosis in it, and LDP has gradually become the first choice for these cancers in clinical work. Although there are several studies about the comparison between LDP and ODP, most are retrospective and there is no agreement in surgical margin, lymph node numbers and prognosis to identify the oncological differences between the two surgical approaches. The investigators' pilot study showed that patients with body and tail pancreatic cancer underwent LDP had a better prognosis compared with the ones undergoing ODP, with no statistics differences in postoperative complications and mortality. This perspective RCT study is performed to confirm whether LDP would improve the prognosis for patients with body and tail pancreatic cancer compared with ODP.


Eligibility: Inclusion Criteria:
  1. Age ≥ 19 years and ≤ 80 years, no gender limitation
  2. Resectable body and tail pancreatic cancer (refer to NCCN 2018)
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  4. Tumor locates at the body and tail of the pancreas without distant metastasis
  5. No celiac trunk and superior mesenteric artery invasion
  6. No operation contraindication, fit for laparoscopic surgery
  7. The expected survival after surgery ≥ 3 months
  8. Patients who are willing and able to comply with the study procedure
  9. Signed informed content obtained prior to treatment
  Exclusion Criteria:
  1. Locally advanced unresectable body and tail pancreatic cancer
  2. Multi-organ and vascular resection needed
  3. Patients undergoing total pancreatectomy
  4. Benign tumor at the body and tail of the pancreas or pancreatic cancer at the head of the pancreas
  5. Distant metastasis or ascites detected by imaging
  6. Severe important organ function impairment (heart, liver, kidney)
  7. Patients who are with other primary malignancy or haematological disorders
  8. Pregnant or nursing women
  9. Patients who have received chemotherapy, radiotherapy and interventional therapy before the pancreatectomy
  10. Patients who have participated in other clinical trials for pancreatic cancer treatment within 3 months

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer

Summary: This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue and normal tissue.

Detailed description: This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue, normal tissue. Biospecimens collected through this protocol will be shared with collaborators in the Pancreatic Cancer Detection Consortium to support projects funded through an NIH U01 grant. Participants will be enrolled when they present for clinically indicated surgical procedures for their possible tumor or pancreas resection or cyst resection, or at a clinically indicated follow-up appointment after their procedure.
  This protocol supports this effort by providing investigators with access to a wide variety of pancreatic tissues and biospecimens for translational studies in pancreatic cancer. This protocol covers the collection of clinical data and biospecimens (blood; malignant, benign, or precancerous pancreatic tumor; and adjacent normal tissues) from patients with, or suspected to have, pancreatic cancer. Additionally, saliva and cyst fluid, may be collected in the future from patients with pancreatic cysts. These will be shared with the Pancreatic Cancer Detection Consortium for further analysis.

Eligibility: Inclusion Criteria:
  -  Males or Females ≥ 18 years of age who have been diagnosed with Pancreatic Cancer (PDAC), Pancreatic Neoplasms (PNs - IPMMs, PanINs and MCNs), pancreatitis and diabetes or no disease/healthy.
  -  Individuals undergoing or have previously undergone a diagnostic procedure (i.e. EUS or ERCP) evaluation or surgery.
  -  Willingness and ability to donate biospecimens for the purpose of research.
  -  Subjects must have had diagnostic procedure or surgery after September 1, 2017.
  Exclusion Criteria:
  -  Individuals under 18 years of age.
  -  Inability to donate biospecimens.
  -  Females pregnant or lactating.

Relevance to patient case: not relevant
Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Application of Newly Developed Endoscopic Ultrasound With Zone Sonography Technology for Diagnosis of Pancreatic Caner

Summary: The purpose of this study is to measure and compare the difference of sound speed between pancreatic cancer and non-pancreatic cancer, and determine the critical value of sound speed for benign and malignant pancreatic cancer. The sensitivity, specificity, accuracy, positive predictive value and negative predictive value for the diagnosis of pancreatic cancer are calculated, so as to evaluate the clinical application value of local sound speed measurement in the diagnosis of pancreatic cancer.

Detailed description: The investigators include patients who are found to have solid pancreatic mass on continuous imaging. All subjects are scanned by Fuji film su-9000 ultrasonic system. After the lesions are found, local sound velocity measurement technology will be used to measure the sound velocity in the lesions. Pathology diagnosis or clinical follow-up results will be regard as diagnostic gold standard to divide the patients into pancreatic cancer and pancreatic cancer group. The investigators will compare the sound velocity value if there is statistically significant difference between the two groups, build the receiver operating characteristic curve, calculation of pancreatic benign and malignant lesions of sound velocity threshold, and and the investigators will calculate the sensitivity, specificity, accuracy, positive predictive value and negative predictive value, to evaluate local sound velocity measurement in the diagnosis of pancreatic cancer clinical application value.

Eligibility: Inclusion Criteria:
  1. Patients aged between 18 and 75, gender is not limited.
  2. Evidence of solid pancreatic lesions have been found on imaging examination, including computed tomography, magnatic resonance imaging and endoscopic ultrasonography.
  3. The lesion was greater 1cm.
  4. The informed consent has been signed.
  Exclusion Criteria:
  1. Patients with serious cardiopulmonary diseases and poor general condition.
  2. Patients with other contraindications to endoscopic ultrasonography.
  3. Cannot or refuse to sign the informed consent.

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

Summary: The purpose of this study is to evaluate the safety and pharmacokinetics of two dose schedules of panitumumab in subjects with advanced solid tumors.


Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of advanced solid tumors that are refractory to at least 1 standard therapy or for which no standard therapy is available and have not received more than 3 prior treatment regimens (not inclusive of hormonal therapies for breast and prostate cancer subjects) for the advanced solid tumor (tumor must be diagnosed by standard criteria for the specific tumor type)
  -  Measurable disease or evaluable (non-measurable) disease per RECIST guidelines (all sites of disease must be evaluated within 28 days before enrollment)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Life expectancy of > 3 months as documented by the investigator
  -  If history of other primary cancer, subject will be eligible only if she or he has:
  -  Non-melanomatous skin cancer, not requiring treatment
  -  Curatively treated cervical carcinoma in situ
  -  Other primary solid tumor curatively treated with no known active disease present for the last 5 years and no treatment administered for the last 3 years
  -  Man or woman 18 years of age or older
  -  Paraffin-embedded tumor tissue (from primary or metastatic tumor tissue) available for immunohistochemistry studies of EGFr expression (biopsy or archived tissue are acceptable). The immunohistochemical EGFr staining and evaluation must be conducted at the designated central laboratory using the DakoCytomation EGFR pharmDXTM kit. Local laboratory EGFr expression is not permitted for the purpose of eligibility in this study
  -  Hematologic function, as follows:
  -  Absolute neutrophil count (ANC) > 1.5 x 109/L
  -  Platelet count > 100 x 109/L
  -  Hemoglobin > 8 g/dL
  -  Renal function, as follows:
  o Creatinine < 2.0 mg/dL
  -  Hepatic function, as follows:
  -  Aspartate aminotransferase (AST) < 3 x ULN (if liver metastases ≤ 5 x ULN)
  -  Alanine aminotransferase (ALT) < 3 x ULN (if liver metastases ≤ 5 x ULN)
  -  Bilirubin < 2 x ULN
  -  Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

Summary: This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.


Eligibility: Inclusion Criteria:
  -  Patients with gastrointestinal stromal tumor (GIST).
  -  Patients who have had disease progression during imatinib therapy with 800 mg.
  -  Ability to understand and willingness to sign a written informed consent document.
  Exclusion Criteria:
  -  Patients with prior or concomitant malignancies other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ.
  -  A history of impaired cardiac function or uncontrolled cardiovascular disease.
  -  Severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107.
  -  Currently taking certain medications that could affect an electrocardiogram result.
  -  Women who are pregnant or breast feeding.
  -  Patients unwilling or unable to comply with the protocol.
  NOTE: Additional inclusion and/ or exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

Summary: This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.

Detailed description: Condition
  Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases.
  Not included:
  Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers.

Eligibility: Inclusion Criteria:
  1. Malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib mesylate.
  2. Spread of the disease to the rest of the body (confirmed by tissue sample) beyond the skin.
  3. Malignant tissue showing activation of certain tyrosine kinases (ABL, ARG, KIT (CD117), or PDGF-R alpha or beta) & preferably within 6 weeks of entry.
  Exclusion Criteria:
  1. Certain leukaemias (abl-mutated), some gastrointestinal stromal tumours (c-KIT-positive) or certain systemic mastocytosis (if c- KIT D816V mutation).
  2. A primary prostate, breast, lung or brain tumour,
  3. Patient has previously been treated with imatinib mesylate except where treatment was more than 6 months previously and there is no suggestion of clinical resistance nor lack of response.
  Other protocol-defined inclusion / exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

Summary: This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.


Eligibility: Inclusion Criteria:
  -  underwent macroscopically curative resection;
  -  immunohistochemically confirmed KIT (CD117)-positive tumors;
  -  judged as being high-risk according to the criteria for risk classification
  Exclusion Criteria:
  -  synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;
  -  received therapy with Imatinib Mesylate prior to study entry;
  -  cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)
  Other protocol-defined inclusion / exclusion criteria may apply.

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)

Summary: This is a extension study of CSTI571B1201 study


Eligibility: Inclusion Criteria:
  - Patients who completed the CSTI571B1201 study
  Exclusion Criteria:
  -
  Other protocol-defined inclusion / exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 70-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (V654A)

Clinical trial: A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene

Summary: In the core study, participants with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. The 10 year extension study allowed participants, who successfully completed the core study, to continue study treatment with imatinib mesylate provided they still benefited from treatment and did not demonstrate safety concerns as per the investigator's opinion.


Eligibility: Inclusion Criteria:
  -  Men and non-pregnant women ≥18 years of age with the histopathologically documented diagnosis of malignant GIST that was unresectable and/or metastatic. Confirmation of KIT (CD117) expression via immunohistochemical analysis of tumor sample was also required
  -  At least one measurable lesion, as defined by Southwestern Oncology Group (SWOG) Solid Tumor Response Criteria, which had not been previously embolized or irradiated
  -  Performance status ≤3 as defined by the Eastern Cooperative Oncology Group (ECOG) criteria, as well as a life expectancy ≥6 months and adequate end organ function defined as follows: Total bilirubin <1.5 times upper limit of normal (ULN), aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) <2.5 x ULN (or <5 x ULN if hepatic metastases were present), creatinine <1.5 x ULN, absolute neutrophil count (ANC) >1.5 x 10^9/L, platelet count >100 x 10^9/L
  Exclusion Criteria:
  -  Patients with fewer than five years of disease-free survival from any other (non-GIST) malignancy except if the other malignancy was not currently clinically significant and did not require active intervention or if the other malignancy was a basal cell skin cancer or a cervical carcinoma in situ
  -  Patients with known brain metastases
  -  Evidence of any of the following disorders: Grade III/IV cardiac failure as defined by the New York Heart Association Criteria, severe concomitant disease, acute or known chronic liver disease (i.e. chronic active hepatitis, cirrhosis) or HIV infection
  -  Chemotherapy or other investigational therapy within four weeks prior to study entry (six weeks for nitrosourea or mitomycin-C) and/or radiotherapy to ≥25% of the bone marrow
  -  Inability to cooperate
  -  Major surgery within two weeks or exposure to other investigational agents within 28 days of entry into the study
  Other protocol-defined inclusion / exclusion criteria may have applied.

Relevance to patient case: definitely relevant