araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: Radiation Therapy as Palliative Treatment of GIST

Summary: Gastrointestinal stromal tumors (GISTs) are generally considered resistant to radiation, but no prospective trials addressing efficacy and tolerability of radiation therapy have been carried out. Limited clinical experience suggests that selected GIST patients may benefit from palliative radiation therapy. The purpose of this prospective, non-randomized, multicenter study is to evaluate efficacy and safety of palliative radiation therapy in GIST patients who have progressive GIST during or after tyrosine kinase inhibitor therapy.

Detailed description: Radiation therapy planning must be based on computerized tomography (CT). External beam radiation must be used. Both 3D and IMRT plans are acceptable. The cumulative radiation dose may range from 30 to 40 Gy as administered in 1.8 to 2.0 Gy fractions, 5 fractions per week. The dose is specified as defined by the ICRU (International Commission on Radiation Units and Measurements) report 50. Response is evaluated using CT 6 and 12 weeks after irradiation. Adverse effects are evaluated using the Common Terminology Criteria for Adverse Effects (CTCAE)version 3.

Eligibility: Inclusion Criteria:
  -  Histologically verified GIST.
  -  Metastatic or locally advanced, inoperable disease.
  -  Adequate systemic treatment has been administered.
  -  One or more growing GIST metastasis present during of after TKI therapy.
  -  The target lesion(s) is measurable.
  -  A written informed consent
  Exclusion Criteria:
  -  WHO performance status is 4.
  -  Estimated life-expectancy less than 3 months.
  -  Radiation planning target volume greater than 3 dm3.
  -  Unmeasurable target lesion. Bone and brain metastases are not accepted target lesions.
  -  Radiation therapy cannot be delivered (e.g. active infection or restlessness.)
  -  Pregnancy.
  -  Systemic GIST treatment with unknown efficacy.
  -  Copies of CT images cannot be sent for central review.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: Current Management of Gastrointestinal Stromal Tumors (GIST) in the Region of Coquimbo

Summary: This is a retrospective analysis and description of the preferred diagnostic and treatment methods employed on GIST on the Region of Coquimbo from 2003 to 2008.


Eligibility: Inclusion Criteria:
  -  All operated patients with GIST
  -  Positive immunohistochemistry
  Exclusion Criteria:
  -  Patients with GIST not operated
  -  Patients with GIST operated on but without immunohistochemistry

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib

Summary: The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or intolerant of Imatinib and/or Sunitinib.


Eligibility: Inclusion Criteria:
  -  Patients with metastatic or locally advanced or unresectable GIST who have intolerance of or disease progression following prior treatment with imatinib and/or sunitinib
  -  ECOG (Eastern Cooperative Oncology Group) performance status ≤2
  -  Must have measurable disease per RECIST (Response Evaluation Criteria in Solid Tumors)
  -  Recovery from toxicity from prior therapy to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 or to subject's baseline status
  -  Adequate organ and marrow function
  -  Sexually active subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months following discontinuation of study drugs.
  -  Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
  Exclusion Criteria:
  -  Therapy with imatinib or sunitinib within 14 days before the first dose of study drug
  -  Chemotherapy, immunotherapy, targeted therapy, chemoembolization, or any investigational drug for the treatment of GIST after the last dose of imatinib or sunitinib
  -  Anticoagulation with warfarin or coumarin-related compounds
  -  Radiation to ≥25% of bone marrow within 28 days of study entry
  -  Treatment with other investigational agents within 28 days of the first dose of XL820
  -  Known central nervous systems metastases
  -  Uncontrolled or intercurrent illness
  -  Pregnancy or breast-feeding
  -  Active bacterial or viral infection requiring systemic treatment

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer

Summary: The purpose of this study is to try to learn more about how small molecule kinase inhibitors work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and similar drugs are more likely to work if a particular DNA change (also known as a mutation) is found in a protein that is important in lung cancer. This protein is called the epidermal growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working, we would like to examine your tumor to learn why these medicines are not working as well. Your tumor will be examined for a variety of things including changes in the DNA of the EGFR. We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins thought to be important in lung cancer.

Detailed description: The goal of this protocol is to determine mechanisms of resistance to epidermal growth factor (EGFR) tyrosine kinase inhibitors (EGFR-TKI) in non-small cell lung cancer (NSCLC). A number of trials have shown small molecule kinase inhibitors to be active agents in the treatment of NSCLC [1]. Clinically these drugs have been noted to produce dramatic but infrequent responses. Mutations in the epidermal growth factor receptor have been shown to correlate with sensitivity to gefitinib and erlotinib[2,3]. However, we know that most patients who have initial responses to EGFR-TKI eventually progress. The mechanism of acquired clinical resistance to these inhibitors in patients incompletely understood.
  This is a protocol to study clinical characteristics and biopsy tissue of patients with non-small cell lung cancer who have had previous clinical response to small molecule kinase inhibitors and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of sensitivity and resistance to small molecule kinase inhibitors.

Eligibility: Inclusion Criteria:
  Patients diagnosed with unresectable or metastatic non-small cell lung cancer (NSCLC) and who fulfill the following eligibility criteria will be considered eligible for this study.
  -  Patient must have previously received treatment with small molecule kinase inhibitors targeting at least, in part, EGFR patients may have received other treatments since treatment with small molecule kinase inhibitors including radiation or chemotherapy)
  -  Development of disease progression while actively receiving tyrosine kinase inhibitor
  -  Signed informed consent
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: The Effect of a Levonorgestrel-releasing Intrauterine Device (IUD) Versus a Copper Containing IUD on Risk of Blood Clots

Summary: This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) on coagulation parameters known to be associated with risk of thrombosis (blood clots). Both the LNG IUD and the copper IUD are FDA approved devices for contraception.
  Women enrolled in this study will be randomized to receive either the LNG IUD or the copper IUD. They will complete a one month bleeding diary prior to insertion of the IUD and again for one month while the IUD is in place. They will undergo phlebotomy (blood draw) at baseline (prior to insertion of the IUD), two and four months. Stored samples will be used to measure D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIIIc, activated partial thromboplastin time (aPTT) and activated partial thromboplastin time plus activated protein C (aPTT + APC). Both groups will undergo a GYN exam with screening for bacterial vaginosis and gonorrhea/chlamydia cultures prior to insertion of the IUD. A brief survey to assess the women's experience with the IUD, including symptomatology and satisfaction with the device, will be conducted at the four months after insertion.


Eligibility: Inclusion Criteria:
  -  Women who desire long-term, reversible contraception
  Exclusion Criteria:
  -  Women with coagulopathies
  -  History of thrombotic events
  -  Pregnancy
  -  Active pelvic infection
  -  Known hypersensitivity to progestin
  -  Undiagnosed vaginal bleeding
  -  Wilson's disease
  -  Sensitivity to copper
  -  Uterine anatomy that precludes insertion of an IUD
  -  Women with multiple sexual partners and history within the last 5 years of alcoholism or drug abuse.
  -  Additionally, women must be greater than 3 months postpartum and have had two months without oral contraceptive pills or 6 months without Depo Provera prior to enrollment.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: Kinase Genotyping of Gastro Intestinal Stomach Tumors (GISTs) From Patients Enrolled in Pfizer A6181112 Phase IIIb Trial

Summary: The purpose of this study is to determine the genetic makeup of gastro intestinal stomach tumors (GISTs) from patients enrolled in the A6181112 phase IIIb trial. Tumor samples will be screened for mutations and this information will be used to determine whether the progression-free survival of patients being treated with the cancer medication sunitinib is related to the underlying genotype of their GIST.

Detailed description: In this companion study, we will analyze the genomic DNA from the GIST tumor specimens of patients enrolled in the in the A6181112 phase IIIb trial at participating U.S. and ex-U.S. medical centers. Specifically, GIST samples will be screened for mutations in KIT gene exons 9, 11, 13 and 17, and PDGFRA gene exons 12, 14 and 18, to determine the primary kinase genotype. Subset analyses will be performed and compared with the overall PFS rates observed in patients with primary and secondary imatinib resistance. Based on data from a previous phase I/II trial, our hypothesis is that patients with either primary or secondary imatinib resistance having a KIT exon 9-mutant or WT GIST will have a longer PFS when treated with sunitinib than patients with exon 11-mutant GIST. We further hypothesize that this difference will be observed among patients treated with high-dose imatinib.

Eligibility: Inclusion Criteria:
  -  Patients enrolled in Pfizer A6181112
  Exclusion Criteria:
  -  Patients who do not consent for analysis of their tumor in this companion study

Relevance to patient case: possibly relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).

Summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first SUNITINIB MALATE(Sutent) should be registered.

Eligibility: Inclusion Criteria:
  Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the surveillance.
  Exclusion Criteria:
  Patients not administered SUNITINIB MALATE(Sutent).

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: A Retrospective Clinical Records Review of Patients Diagnosed With Gastrointestinal Stromal Tumour at Two Tertiary Institutes in Singapore

Summary: To review the characteristics and treatment of gastrointestinal tumours at the two tertiary centres in Singapore

Detailed description: A retrospective clinical records review of patients diagnosed with gastrointestinal stromal tumour (GIST) in the two tertiary centres in Singapore i.e. Singapore General Hospital and National University Hospital.
  Gastrointestinal tumours are the most common soft-tissue tumours of the gastrointestinal tracts. Remarkable progress has been made during the last several years in the diagnosis and treatment of GIST. Understanding of the molecular pathogenesis of GIST which is linked to deregulated KIT tyrosine-kinase activity has improved diagnosis, such that GIST is now more frequently and specifically identified. More importantly, systemic tyrosine kinase inhibitor, imatinib, has been used successfully in the treatment of GIST patients with advanced or unresectable disease.
  GIST has been reviewed in the Western literature but there is a lack of Asian data. The review will help us to better understand the disease in our population.Furthermore we will also examine several unresolved issues in the Western literature by looking into our local data. These include required duration of imatinib therapy, role of imatinib in the adjuvant setting (application of chemotherapy after macroscopically complete removal of tumour) and role of combination therapies.
  The medical records of all patients diagnosed with the disease at the two centres will be reviewed.
  Analysis of the results aims to:
  1. to compare the characteristics of the GIST (epidemiology, site, morphology, immunohistochemistry profile) in our centres compared to the well-published literature.
  2. to compare the treatment regimen and results of our centres compared to others
  3. to review the role of chemotherapy in the adjuvant settings in the centres.

Eligibility: Inclusion Criteria:
  -  Patients diagnosed with Gastrointestinal stromal tumor.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

Summary: This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.


Eligibility: Inclusion Criteria:
  -  Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
  -  At least one measurable site of disease on CT/MRI scan
  -  PS≤2
  -  Normal organ, electrolyte, and bone marrow function
  Exclusion Criteria:
  -  Previous treatment with nilotinib or any other drug in this class or other targeted therapy
  -  Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry
  -  Impaired cardiac function
  -  Use of coumarin derivatives (i.e. warfarin)
  -  Women who are pregnant or lactating
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section

Summary: This is a pilot study of up to 10 women, which will test the hypothesis that the placement of copper IUDs through the uterine incision at the time of uncomplicated elective C-section is technically feasible and acceptable to women seeking long-term contraception.

Detailed description: Women will be enrolled in this study during late prenatal care. Consent for placement of the IUD will be verified prior to elective C-section. After removal of the placenta, the copper IUD will be placed through the incision at the fundus and the tail strings will be delivered through the cervix. Data will be collected about patient bleeding and possible infection during the immediate postoperative period. The visibility of the strings will be verified at discharge and at 2 and 6 weeks postpartum. Fundal placement of the IUD will be verified by ultrasound at the patient's last visit.

Eligibility: Inclusion Criteria:
  -  Pregnant woman
  -  Requires elective C-section
  -  Desires long-term contraception
  Exclusion Criteria:
  -  Contraindications to copper IUD

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
  PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

Detailed description: OBJECTIVES:
  -  To evaluate the safety and efficacy of imatinib mesylate in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.
  OUTLINE: This is a multicenter study.
  Patients receive oral imatinib mesylate daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of gastrointestinal stromal tumor (GIST)
  -  Hepatic metastasis meeting the following criteria:
  -  No more than 3 hepatic metastases
  -  Clinically diagnosed as surgically resectable with no macroscopic residual tumor
  -  Synchronous hepatic metastasis allowed provided primary tumor is also resectable
  -  No metastatic tumor that requires radiofrequency ablation and/or microwave coagulation therapy to control the disease
  -  No extrahepatic metastasis
  -  No history of GIST recurrence
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-1
  -  Leukocyte count ≥ 3,000/μL
  -  Neutrophil count ≥ 1,500/μL
  -  Hemoglobin ≥ 8.0 g/dL
  -  Platelet count ≥ 75,000/μL
  -  Total bilirubin ≤ 2.0 mg/dL
  -  ALT and AST < 120 IU/L
  -  GTP < 210 IU/L
  -  Not pregnant
  -  No poorly controlled diabetes mellitus
  -  No NYHA class III-IV cardiac function
  -  No hepatitis B or hepatitis B carriers
  -  No other malignancy requiring treatment
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior imatinib mesylate
  -  No prior interventional radiology for metastatic disease
  -  No other concurrent treatment, including surgery or radiotherapy, for metastatic lesions

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

Summary: RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor.
  PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

Detailed description: OBJECTIVES:
  -  To evaluate the safety and efficacy of surgery in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.
  OUTLINE: This is a multicenter study.
  Patients undergo surgical resection of hepatic metastasis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of gastrointestinal stromal tumor (GIST)
  -  Hepatic metastasis meeting the following criteria:
  -  Clinically diagnosed as surgically resectable with no macroscopic residual tumor
  -  No more than 3 hepatic metastases
  -  Synchronous hepatic metastasis allowed provided primary tumor is also resectable
  -  Does not require radiofrequency ablation and/or microwave coagulation therapy to control the disease
  -  No extrahepatic metastasis
  -  No history of GIST recurrence
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-1
  -  Leukocyte count ≥ 3,000/μL
  -  Neutrophil count ≥ 1,500/μL
  -  Hemoglobin ≥ 8.0 g/dL
  -  Platelet count ≥ 75,000/μL
  -  Total bilirubin ≤ 2.0 mg/dL
  -  ALT and AST < 120 IU/L
  -  GTP < 210 IU/L
  -  Not pregnant
  -  No poorly controlled diabetes mellitus
  -  No NYHA class III-IV cardiac function
  -  No hepatitis B or hepatitis B carriers
  -  No other malignancy requiring treatment
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior interventional radiology for metastatic disease
  -  No prior or concurrent imatinib mesylate
  -  No other concurrent treatment

Relevance to patient case: not relevant
Patient case: 49-year-old female with Gastrointestinal stromal tumor. Genetic variant: KIT Exon 9 (A502_Y503dup). Other conditions: None.

Clinical trial: A Study of Nilotinib Versus Imatinib in GIST Patients

Summary: This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).


Eligibility: Inclusion Criteria:
  1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
  -  have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or
  -  recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
  2. At least one measurable site of disease on CT/MRI scan
  3. Performance status ≤ 2 (capable of self-care but unable to carry out any work)
  4. Normal organ, electrolyte and marrow function
  Exclusion Criteria:
  1. Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.
  2. Disease progression during adjuvant therapy with imatinib
  3. History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
  4. Impaired cardiac function
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant