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

Clinical trial: The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes

Summary: -  This is a phase II, prospective, single-center, non-randomized, non-controlled study.
  -  Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer. The potentially increasing false negative rate of SNB was concerned if the sonographic abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.


Eligibility: Inclusion Criteria:
  -  histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy
  -  abnormal axillary lymph node was found by ultrasound examination before SLNB (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm)
  -  ultrasound-guided FNA cytology of these nodes were performed
  -  the result of FNA cytology was negative (no tumour cell was found)
  -  patient planed to perform SLNB
  Exclusion Criteria:
  -  pathological diagnosed ductal carcinoma in situ by excisional biospy
  -  abnormal axillary lymph node was found by ultrasound examination but FNA cytology of these nodes were not performed
  -  the result of FNA cytology was positive (tumour cell was found)
  -  T4d tumour
  -  patient has recieved neo-adjuvant system therapy

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

Clinical trial: Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy

Summary: We will observe if ICG fluorescence correlates with margins of breast tumours after iv injection of the contrast agent

Detailed description: In the operating room:
  ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.
  The surgeon will remove the tumour (and the axillary lymph nodes) as usual.
  Optionally, peroperative "in vivo" imaging of the dissection of the tumour using the PDE camera will be performed.
  In the Laboratory of Pathology:
  The "fresh" tumorectomy piece will be processed as usual, and the thick sections for the evaluation of the margins as well as the tissues samples from each margins will be imaged using the PDE in comparison with the fluorescence in the mid part of the tumour and the fluorescent areas will be so delimited (and later analyzed in comparison with standards of known fluorescence intensity).
  After fixation, the tumoral tissues will be thereafter processed "as usual".
  If fluorescent foci are identified at the level of the axillary piece (in case of CALND), they will be dissected and processed as other lymph nodes. Additionally, metastatic lymph nodes -if present- will also be controlled for their microscopic fluorescence or not.
  Using the near-infrared fluorescence microscope, the slides corresponding to the macroscopically fluorescent structures will be analyzed.

Eligibility: Inclusion Criteria:
  -  Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection,
  -  Informed consent form signed.
  Exclusion Criteria:
  -  Diagnosis of mammary cancer established by "gross" biopsy,
  -  Age less than18 years old.
  -  Inability to give informed consent.
  -  History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
  -  Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
  -  Documented coronary disease.
  -  Advanced renal impairment (creatinine > 1,5mg/dl).
  -  During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
  -  Pregnancy, breastfeeding

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

Clinical trial: Study of the ICG Distribution in Breast Tumours or in Axillary Lymph Nodes of Patients After Neoadjuvant Therapy

Summary: We will verify if IV injected ICG may colour breast tumors and axillary lymph nodes after neoadjuvant therapy (chemo- or hormonotherapy)

Detailed description: In the operating room:
  ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.
  Optionally, dynamic NIR imaging centered on the tumor bearing breast will be acquired during the 15 minutes after injection (in comparison with standards of known fluorescence intensity).
  Optionally and in case of tumorectomy, peroperative "in vivo" imaging of the surgical dissection will be acquired. The tumour and/or the mammary piece (and the axillary piece) of dissection will be directly imaged "ex vivo" using the PDE camera (in comparison with standards of known fluorescence intensity).
  In the Laboratory of Pathology:
  The fresh mammary piece will be processed as usual, but the "gross-thick" sections will be imaged using the PDE and the fluorescent areas will be defined (and later analyzed in comparison with standards of known fluorescence intensity).
  After fixation, the tumoral tissues as well as - if identified - non tumoral fluorescent foci will be thereafter processed "as usual".
  All the slides obtained will be analyzed using the NIR fluorescent microscope for the presence or not of detectable ICG and the ICG-positive tissues or compartments (vascular spaces, interstitial spaces, normal and/or tumoral cells, macrophages…) will be determined.
  If fluorescent foci are identified at the level of the axillary piece, they will be isolated and analyzed like the other lymph nodes. Using the NIR fluorescent microscope, these isolated macroscopically fluorescent structures will be analyzed (lymph node? Other?).
  Additionally, metastatic lymph nodes will also be controlled for their microscopic fluorescence or not.

Eligibility: Inclusion Criteria:
  -  Patients with histopathological diagnosis of mammary cancer who have received neoadjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection,
  -  Informed consent form signed.
  Exclusion Criteria:
  -  Diagnosis of mammary cancer established, either by tumorectomy, or by "gross" biopsy,
  -  Age less than18 years old.
  -  Inability to give informed consent.
  -  History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
  -  Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
  -  Documented coronary disease.
  -  Advanced renal impairment (creatinine > 1,5mg/dl).
  -  During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
  -  Pregnancy, breastfeeding

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

Clinical trial: Genomic Signatures to Predict Treatment Response

Summary: A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively evaluate the microarray-based, genomic test as a predictor of axillary lymph node response. Also, to determine whether the probability of achieving negative axillary nodes, is sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to support omitting axillary dissection.


Eligibility: Inclusion Criteria:
  -  Clinical status of lymph nodes must be available
  -  Sonographical status of lymph nodes must be available
  -  Patients must consent to documentation of cancer treatment
  -  Histologic diagnosis of invasive breast cancer, clinical stage T1-4, M0 (non-inflammatory T4c)
  -  Patients scheduled for neoadjuvant chemotherapy
  -  Treatment with a 3-weekly FEC or AC regimen (3-4 cycles) followed by 3-4 cycles of q3 weekly docetaxel or paclitaxel.
  -  Local HER2 status of tumor biopsy must be negative.
  Exclusion Criteria:
  -  The patient has a prior history of invasive or metastatic breast cancer.
  -  The patient had prior excisional biopsy of the primary invasive breast cancer.
  -  The patient had prior ipsilateral sentinel axillary lymph node biopsy for breast cancer.
  -  The patient cannot safely or feasibly undergo biopsy of the primary tumor.
  -  The patient has a diagnosis of Stage IV (distant metastatic) breast cancer.
  -  The patient has proven HER2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining.

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

Clinical trial: Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer

Summary: Fatigue is common in cancer patients receiving adjuvant chemotherapy. To further understand the mechanism of fatigue and search for potential biomarkers, we will conduct a prospective study with breast cancer patients receiving adjuvant chemotherapy.

Detailed description: Patients with breast cancer undergoing adjuvant systemic chemotherapy based on the use of anthracyclines will be screened before the start of chemotherapy.
  Patients whose scores on the brief fatigue inventory (BFI) increase after having received the first cycle of chemotherapy will be considered as having manifested fatigue. The patients whose fatigue won't worse following the first cycle of chemotherapy will be used as controls. We will collect blood samples of both groups before and 21 days after the start of chemotherapy. We will analyze the following biomarkers: IL2, IL10, TNF and TGFB-1 measured by amplification reaction; FSH, LH, estradiol, DHEA, DHEAS and cortisol hormones measured by chemiluminescent enzyme immunometric assay

Eligibility: Inclusion Criteria:
  -  Non metastatic breast cancer;
  -  Patients undergoing adjuvant chemotherapy
  Exclusion Criteria:
  -  hypothyroidism;
  -  Depression;
  -  anemia;
  -  heart disease or decompensated hypertension

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

Clinical trial: Intraductal Papillary Mucinous Neoplasm With Malignant Change

Summary: Purpose:
  To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012.
  Hypothesis: According to 2012 consensus guidelines, enhanced solid component and main pancreatic duct size of larger than 10 mm will be significant.

Detailed description: 1. Purpose
  -  To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012
  2. Enroll criteria
  -  Patient who is suspected to have pancreas IPMN on imaging
  -  Interval between imaging study and surgery is less than 2 months
  -  Who is scheduled for surgery due to IPMN

Eligibility: Inclusion Criteria:
  -  Patients who is suspected to have IPMN by imaging study or clinician
  -  Time interval between imaging study and surgery less than 2 months
  Exclusion Criteria:
  -  Patients who have pathology results not by surgery
  -  Who is less than 20 years old
  -  Who cannot voluntarily agree study design

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

Clinical trial: A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

Summary: The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed breast adenocarcinoma.
  -  Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample.
  -  Prior first-line systemic therapy in the metastatic setting.
  -  Demonstrated progression of disease by radiological or clinical assessment.
  -  Female patient, aged ≥18 years old.
  -  Estimated life expectancy >3 months.
  -  Normal Left ventricular function
  -  Adequate haematological, hepatic and renal functions.
  -  For women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception.
  -  Ability to swallow oral capsules or tablets.
  Exclusion Criteria:
  -  More than two lines of chemotherapy with or without targeted therapy in the metastatic setting.
  -  Previous treatment with bevacizumab within 3 months of first dose of Investigational Medicinal Product.
  -  Active central nervous system metastases, cerebral oedema, and/or progressive growth.
  -  Patients with impaired cardiac function.
  -  Uncontrolled arterial hypertension
  -  Patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events
  -  Serum potassium level below Lower Limit of Normal
  -  Uncontrolled hypothyroidism.
  -  Pregnant or breastfeeding women.

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

Clinical trial: Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research

Summary: The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel surgical navigation system.

Detailed description: Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. However, the existing methods, including methylene blue and nuclides, possess low efficiency and effectiveness in mapping SLNs, and to a certain extent exert side effects during application. Indocyanine green (ICG), as a fluorescent dye, has been proved reliable usage in SLN detection by several other groups. In this paper, we introduce a novel surgical navigation system to detect SLN with ICG. This system contains two charge-coupled devices (CCD) to simultaneously capture real-time color and fluorescent video images through two different bands. During surgery, surgeons only need to follow the fluorescence display. In addition, the system saves data automatically during surgery enabling surgeons to find the registration point easily according to image recognition algorithms. We aim to show that the usage of our surgical navigation system with ICG to detect SLNs in breast cancer patients is technically feasible.

Eligibility: Inclusion criteria: (Before the test, all the subjects required for meeting the entry requirements before they join the group)
  -  female patients;
  -  The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer;
  -  tumor diameter ≤ 3cm;
  -  No clinical examination of suspicious axillary lymph node-positive;
  -  diagnosed clinical conditions can be directly surgery as I, II breast cancer patients;
  -  preoperative clinical or radiologic evidence without distant metastases (M0);
  -  signed informed consent.
  Exclusion criteria: (Before the test, the subjects under any one of items to meet the requirements can not be enrolled)
  -  Sentinel lymph node biopsy history had received surgery or axillary area;
  -  multi-center breast cancer or multiple lesions;
  -  clinical axillary lymph node metastasis have been found;
  -  mammary area had received neoadjuvant chemotherapy or radiotherapy;
  -  inflammatory breast cancer;
  -  pregnancy;
  -  no personal freedom and independent civil capacity.
  Exclusion criteria: (trials, subjects necessary to meet the requirements of any one item, exit the clinical trial research.)
  -  severe allergic reaction occurs;
  -  persistent allergic reaction;
  -  subjects were required to withdraw from a clinical trial;
  -  researchers consider it not appropriate to continue to participate in the clinical trial investigator.

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

Clinical trial: Breast Cancer During Pregnancy

Summary: Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.


Eligibility: Inclusion Criteria:
  -  Patients with breast cancer diagnosed during pregnancy
  Exclusion Criteria:
  -  Patients who refuse informed consent

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

Clinical trial: Breast Cancer Tumor Heterogeneity

Summary: Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.


Eligibility: Inclusion Criteria:
  1. Women > age 18 with capacity to consent
  2. Invasive breast cancer identified on CNB at AAMC within 45 days of study consent
  3. IHC biomarkers performed on original CNB (including HER2)
  4. Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or
  5. Multifocal or multicentric tumors
  Exclusion Criteria:
  1. Men
  2. Women with HER2 positive tumors detected on CNB specimens
  3. Women receiving neoadjuvant chemotherapy
  4. Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment
  5. Women whose IHC marker results were inconclusive on CNB or not performed -

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

Clinical trial: Integrating Palliative Care Into Self-Management of Breast Cancer

Summary: The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care and to facilitate its timely integration into self-management of their breast cancer. The MCC will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months following enrollment. The intervention group will receive the MCC, and the attention-control group will receive a symptom management toolkit. Participants' family caregivers will also be enrolled to provide information on patients' self-management. Investigators hypothesize that users of MCC, as compared to attention-control participants, will demonstrate improved knowledge, feelings, and behaviors related to self-management of their cancer care. This innovative research can help to establish palliative care as a mainstay of self-management interventions that target serious illnesses.


Eligibility: Inclusion Criteria:
  -  Over the age of 21
  -  Stage I-IV breast cancer
  -  Live in the State of Connecticut
  -  Speak English
  -  Receiving any kind of treatment for breast cancer
  -  Prognosis of at least 6 months

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

Clinical trial: A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)

Summary: The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Subjects with histologically confirmed malignant melanoma
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):
  -  PS 0 to 1
  -  PS 2
  -  Previously treated unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status
  -  Subjects must have experienced evaluable Response Evaluation Criteria In Solid Tumors (RECIST 1.1)-defined disease progression
  -  Prior treatment with chemotherapy, interferon (adjuvant setting), Interleukin (IL-2), BRAF/MEK inhibitors for subjects with known BRAF mutations, Mitogen-activated or extracellular signal- regulated protein kinase (MEK) inhibitors for Neuroblastoma Ras Viral (v-ras) oncogene homolog (NRAS) mutations, and cKIT inhibitor subjects with known cKIT mutations are allowed
  -  Patients with CNS metastases are eligible:
  -  if CNS metastases are treated, patients are asymptomatic or neurologically returned to baseline
  -  if they have previously untreated CNS metastases and are asymptomatic
  -  if they have leptomeningeal metastases, are treated and asymptomatic or neurologically returned to baseline with life expectancy > 3 months
  -  Patients with a known history of Grades 3-4 immune-related adverse reactions during/after anti-CTLA-4 therapy if all toxicities have resolved at least to Grade 1
  Exclusion Criteria:
  -  Subjects with untreated, active Central Nervous System (CNS) metastases are excluded

Relevance to patient case: not relevant