araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Summary: To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.

Detailed description: This dose escalation/dose expansion study will evaluate the combination of orally administered BGJ398 in combination with orally administered BYL719. During the dose escalation part, the MTD of the combination will be determined in patients whose advanced or metastatic tumors express mutations to PIK3CA. Once the MTD has been determined, the expansion part will begin. Patients will be addd to one of three arms based on the disease type and genetic changes. Patients with metastatic colorectal cancer are not eligible for participation in the expansion part.

Eligibility: Inclusion Criteria:
  -  Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy exists
  -  Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)
  -  Measurable disease defined by RECIST v1.1
  -  ECOG performance status of ≤2
  Exclusion Criteria:
  -  Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part)
  -  Colorectal cancer (for patients enrolled to expansion part)
  -  Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus
  -  Use of medications that increase serum levels of phosphorus and/or calcium
  -  Inorganic phosphorus outside of normal limits
  -  Total and ionized serum calcium outside of normal limits

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Magnesium and Rotational Thromboelastometry (ROTEM) in Colorectal Cancer Surgery

Summary: Magnesium sulphate is given to the patients during the colorectal cancer surgery under the hypothesis that it would attenuate the postoperative hypercoagulability. The investigators intend to characterize the changes of coagulation in colorectal cancer patients by using the point-of-care device after the infusion of magnesium sulphate.


Eligibility: Inclusion Criteria:
  -  The patients undergoing a laparoscopic colorectal cancer surgery
  Exclusion Criteria:
  -  Renal disease
  -  Hepatic disease
  -  Neuromuscular disease
  -  Coagulation disorder
  -  Cardiopulmonary disease

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: XL999 Administered Intravenously to a Subject With Advanced Malignancies

Summary: Cancer is a worldwide clinical and economic problem. Conventional approaches to treating cancer include surgery, radiotherapy, and cytotoxic chemotherapy as single modalities or as combined therapies. Recently, targeted therapies including antibodies and small molecule inhibitors have also demonstrated clinical benefit. It is now possible to study different genetic lesions involved in cancer types due to advances in genomic methodologies. The investigational drug in this study, XL999 inhibits multiple receptor tyrosine kinases, including VEGF receptor (VEGFR2/KDR), platelet derived growth factor receptors (PDGFRβ), fms-like tyrosine kinase receptor 3 (FLT3), fibroblast growth factor receptors (FGFR1, FGFR3), RET, and KIT, and thus, interferes with multiple cellular processes simultaneously and will likely have effects on the integrity of tumor neovasculature and angiogenesis. Together with the ability to induce a novel cell cycle arrest, the spectrum of activities that XL999 exhibits may reduce both tumor cell proliferation and angiogenesis in the clinic.
  The rationale and purpose of this maintenance study is to allow a subject receiving clinical benefit from XL999 to continue treatment.


Eligibility: Inclusion Criteria:
  -  The subject is eligible to continue to receive XL999 in the absence of progressive disease and unacceptable XL999-related toxicity.
  Exclusion Criteria:
  -  Progressive disease.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Phase Ib Study of Fruquintinib in Patients With Metastatic Colorectal Carcinoma

Summary: Fruquintinib is a novel oral small molecule compound discovered and developed by Hutchison MediPharma that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts.Based on first-in-human study, both 4mg QD and 5mg 3wks on/1wk off are safety and efficacy, this phase Ib study is to evaluable the safety, tolerability and efficacy of these 2 regimens with mCRC failed 2nd therapy or more and to determine the recommended dose and regimen in phase II/III study.

Detailed description: This is a phase Ib, randomize, interventional, open-label, multicenter study to provide fruquintinib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist.
  The primary endpoint of this study will be safety.

Eligibility: Inclusion Criteria:
  -  ≥ 18 and ≤ 70 years of age , with ≥ 40Kg
  -  Histological or cytological confirmed colorectal cancer
  -  ECOG performance status of 0-1
  -  Standard regimen failed or no standard regimen available
  -  Adequate hepatic, renal, heart, and hematologic functions
  -  At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
  -  Signed and dated informed consent.
  -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Any factors that influence the usage of oral administration
  -  Evidence of CNS metastasis
  -  Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
  -  Abuse of alcohol or drugs
  -  Less than 4 weeks from the last clinical trial
  -  Previous treatment with VEGFR inhibition
  -  Disability of serious uncontrolled intercurrence infection
  -  Proteinuria ≥ 2+ (1.0g/24hr)
  -  Uncontrolled hemorrhage in GI
  -  Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
  -  Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG
  -  Bone fracture or wounds that was not cured for a long time
  -  Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

Summary: This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to adult patients with histologically confirmed GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.

Detailed description: Patients will be enrolled in two groups. Group 1 will enroll patients who are not candidates for surgery. Group 2 will enroll patients who are surgical candidates. Patients from both groups will be evaluated for tumor response and progression by MRI every 8 weeks until disease progression or discontinuation from study using RANO criteria.

Eligibility: Inclusion criteria:
  1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time of diagnosis or prior relapse.
  2. Written documentation of local or central laboratory determination of amplification or translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in FGFR1, FGFR2,or FGFR3
  3. RANO defined tumor progression by MRI in comparison to a prior scan
  4. Patients must have received prior external beam radiotherapy and temozolomide.
  Exclusion criteria:
  1. History of another primary malignancy
  2. Prior or current treatment with a FGFR inhibitor
  3. Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids
  4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously on an EIAED, the patient must be off of it for at least two weeks prior to study treatment.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Diagnostic Accuracy of Ferumoxytol-Enhanced MRI for Detecting Lymph Node Metastases in Colorectal Cancer

Summary: The purpose of this study is to determine the diagnostic accuracy of ferumoxytol-enhanced MRI in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal cancer.

Detailed description: This study will investigate the accuracy of ferumoxytol-enhanced MRI in detecting lymph nodes that have been invaded by tumor cells in patients with colorectal cancer. This study will be performed in addition to any ongoing routine care and will not serve as a substitute for any imaging tests that would be routinely performed prior to surgery.

Eligibility: Inclusion Criteria:
  -  Patients 18 years of age or older with histologically confirmed colorectal cancer
  -  Planned for surgical resection of tumor
  Exclusion Criteria:
  -  Contraindications for MRI
  -  Contraindication or known allergy to ferumoxytol or parental iron products (e.g. iron sucrose, iron dextran, etc.)
  -  Planned chemotherapy or radiation treatment prior to surgical resection of primary tumor
  -  Uncontrolled serious medical illness
  -  Unable or unwilling to give informed consent
  -  Pregnancy
  -  Breastfeeding women
  -  Clinically documented or known risk of primary or secondary iron overloading including history of thalassemia, sickle cell anemia, hereditary hemochromatosis or first-degree relative with known hemochromatosis, multiple transfusions for any reason within the past 5 years, or use of over-the-counter ferrous sulfate without the supervision of his/her doctor

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Does Surface Tell us About the Invasive Front in Colorectal Cancer

Summary: The purpose of this study is to investigate the invasive front in growth mode (expanding or infiltrative) and dedifferentiation (tumor budding) and comparing these with the tumor surface (polypose or flat) + / - ulceration in surgical specimens at colorectal cancer.

Detailed description: Timetable: From 1 August 2013 to 31 July 2014.
  Organisational arrangements: The project is deleted from the pathology department, Roskilde Hospital, and surgical department, Roskilde Hospital.
  inclusion criteria All colorectal surgical specimens having cancer were the patient did not receive neoadjuvant treatment received in the pathology department in accordance with current guidelines with the cutting of the tumor area in parallel slices and photographed, so there is macroscopic photo documentation.
  Microscopic tumors classified as adenocarcinoma of glandular type, mucinous adenocarcinoma, signet ring cell carcinoma.
  When the specimens is received at the department of pathology and is included in the study the pathologist report is registered in a local database.

Eligibility: Inclusion Criteria:
  -  All surgical preparations from patients with colorectal cancer that did not receive neoadjuvant treatment received in the pathology department in accordance with current guidelines with the cutting of the tumor area in parallel slices and photographed, so there is macroscopic photo documentation.
  Microscopic tumors classified as adenocarcinoma of glandular type, mucinous adenocarcinoma, signet ring cell carcinoma.
  Exclusion Criteria:
  -  All surgical preparations from patients with colorectal cancer where the patient received neoadjuvant therapy or when surgery preparation could not be received by current guidelines and all preparations where it is not possible to obtain macroscopic image of the parallel slices.
  Microscopic tumors that can not be classified as adenocarcinoma of the glandular type, mucinous adenocarcinoma or signet ring cell carcinoma excluded.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Novel Patent Platform of Detection of Circulating Tumor Cells to Early Detect Colorectal Cancer Recurrence

Summary: The best strategy to prevent colorectal cancer (CRC) death lies in early detection and early treatment at the local disease status of tumor. After curative resection of tumor, there are about 5~10% of stage I, 20~30% of stage II and 40~50% of stage III patients suffering metastasis during subsequent follow-up periods. Although carcinoembryonic antigen (CEA) is the most widely used biomarker for postoperative monitoring of recurrence on asymptomatic patients, it is difficult to use CEA as biological marker to identify the population with high recurrent risk in patients with early-stage cancer because lower than half of patients with early-stage cancer do not have CEA elevation. For improving the survival of patients with early-stage CRC, we need effort to search more useful biological markers to predict the risk of tumor recurrence and to select out patients with high recurrent risk to receive preventive adjuvant therapy.
  Circulating tumor cells (CTCs) in the blood play an essential role in cancer metastasis. Hence, the detection of CTCs and subsequent analysis can potentially revolutionize the cancer care ranging from screening, diagnosis, monitoring, to drug selection and so on. In the past decade, many methods using magnetic beads (CellSearch), filtration (RareCelletc), or flow cytometry have been developed but all of them have the shortcomings from low sensitivity, low purity, to unable to retrieve cells for downstream molecular analysis and cell culture. Recently, a biomimetic affinity based microfluidic platform has overcome abovementioned technical challenges. Importantly, by using only 2 ml of peripheral blood, Sinica's team has shown that the enumeration of CTCs increases with the CRC disease progression, where the mean CTC counts are 3, 15, 29 and 60 per ml for the stages I, II, III and IV, respectively. The results imply that monitoring CTC enumeration serially may serve as a prediction marker to identify the CRC patients with high probability of recurrence. The aims of this study are toestablishing CTC platform standard operation protocol (SOP) that leads to certification of ISO 13485 and to establish CTC criteria and evaluate its prediction power of early detection of colorectal cancer recurrence.


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of colorectal cancer
  Exclusion Criteria:
  -  age younger than 20
  -  Pregnancy
  -  Inmates

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: RNA Extraction and Amplification From Biopsy Specimens in Subjects With Metastatic Renal Cell Carcinoma (AGS-NTS-017)

Summary: The primary objective is to evaluate methods for AGS-003 production from surgical (stage I) and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.


Eligibility: Inclusion Criteria:
  A subject with metastatic RCC, who in the opinion of the treating physician, is a potential candidate for inclusion in this study if all of the following criteria apply:
  1. 18 years of age or older.
  2. Suspected RCC, in the opinion of the investigator
  3. Availability of either:
  -  Nephrectomy or other surgically removed tissue (Stage I); or,
  -  Metastatic RCC biopsy tissue utilizing needle or core biopsy procedures (Stage II).
  4. ≥5 biopsy specimens available from BRPC.
  -  Subjects who are having a surgical procedure (i.e. metastasectomy, nephrectomy) will have these core biopsies obtained from the surgical specimen, per the BRPC protocol.
  5. Not currently being treated with systemic therapy.
  Exclusion Criteria:
  1. Tumor tissue is committed to other use or inadequate for RNA analysis.
  2. Insufficient tissue is collected in the BRPC.
  Expansion Cohort for Genitourinary Cancers:
  Inclusion Criteria:
  1. 18 years of age or older
  2. Suspected bladder, prostate, or testicular cancer, in the opinion of the investigator.
  3. Availability of surgically removed tissue or biopsy tissue.
  4. At least 2 biopsy specimens available from BRPC
  5. Not currently being treated with systemic therapy.
  Exclusion Criteria:
  1. Tumor tissue is committed to other use or inadequate for RNA analysis.
  2. Insufficient tissue is collected in the BRPC.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker

Summary: Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Detailed description: Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.Therefore, our study is designed to investigate that colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Eligibility: Inclusion Criteria:
  - Age between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions < 1.5 upper normal limit (UNL).
  Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent
  Exclusion Criteria:
  - Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI

Summary: Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular architecture on lesion surface.The histology of early colorectal lesions could be predicted under NBI view.However,its capability for estimating invasion depth remains to be verified.The study is based on the hypothesis:NBI can predict histology and invasion depth,combined with the verification of microvessel count and MMP-7 expression.

Detailed description: The microvessel count (MVC) is a classical method of assessing histologic grade.To verify whether NBI could predict histology through microvascular architecture,we measured lesion microvessels by immunohistochemistry.On the other hand,we applied immunohistochemistry of matrix metalloproteinase-7 (MMP-7) to validate the capability of NBI for estimating invasion depth.MMP-7 is directly involved in the processes of growth, invasion, and metastasis of colorectal cancer.Our target was to clarify the diagnostic accuracy of magnifying NBI in early colorectal lesions,combined with the verification of microvessel count and MMP-7 expression.

Eligibility: Inclusion Criteria:
  -  patients of early colorectal lesions with capillary pattern(CP) type II&III,initially detected by white-light view and then examined by NBI with magnifying endoscopy.
  Exclusion Criteria:
  -  lesions with CP type I;
  -  CP type III lesions with an obvious appearance of advanced cancer;
  -  lesions that had underwent biopsy;
  -  patients with inflammatory bowel disease(IBD) or familial adenomatous polyposis(FAP)
  -  patients with previous colorectal surgery;
  -  having conditions associated with cardiac,hepatic,renal,and coagulopathy diseases.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Core Stability Program in Colorectal Cancer Survivors

Summary: The purpose of this study is to determine the effects of physical training program to improve deep stabilizer muscle in colorectal cancer survivors

Detailed description: Background: Colorectal cancer is the third most common cancer when considering both genders. Musculoskeletal alterations have been described related to techniques used during surgery, that it produces an inhibition of deep abdominal muscles. These muscles are in charge of lumbopelvic stabilization muscle linked to reduced ability to maintain independence in daily activity life that could have affected their quality of life
  Objective: The aim objective will be evaluated short and long-term effects of physical activity program for muscle stabilization.
  Methods: 20 colorectal cancer survivors will be recruited from the Department of Oncology of Clínico San Cecilio Hospital. Patients will be randomized in physical activity program group and usual care group. Physical activity groups will receive an eight week program form improve the muscle stabilization.
  Discussion: Researchers attempts to increase the fitness level and reduce musculoskeletal disorders in colorectal cancer survivors through a physical activity interventions focusing in muscle stabilization.

Eligibility: Inclusion Criteria:
  -  Patients under partial colorectal resection to treat colon cancer
  -  Diagnosis of I, II or IIIa stage of colorectal cancer
  -  Completion of adjuvant therapy (except for hormone therapy)
  -  Medical clearance of participation
  Exclusion Criteria:
  Participants will be excluded if they presents with cancer recurrence or if they will have undergone previous abdominal surgeries or will be diagnosed with concomitant conditions, such as previous lower-back pain or musculoskeletal conditions (e.g., osteoarthritis, fibromyalgia or chronic fatigue syndrome).

Relevance to patient case: not relevant