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

Clinical trial: Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer

Summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

Detailed description: A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.

Eligibility: Inclusion Criteria:
  -  Female or male aged 25 or over
  -  Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )
  -  Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.
  -  At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
  -  Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification
  Exclusion Criteria:
  -  Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)
  -  Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given > 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
  -  With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment.
  -  Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
  -  Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.

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

Clinical trial: Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer

Summary: Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer


Eligibility: Inclusion Criteria:
  -  breast cancer with no metastasis receiving adjuvant chemotherapy
  Exclusion Criteria:

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

Clinical trial: An Observational Study to Register the Incidence of Breast Cancer and Current Clinical Care Patterns in Kenya

Summary: This observational study, conducted by the Kenya Society for Hematology and Oncology, will develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical and pathological characteristics, treatment and clinical outcome will be collected from newly diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry cohort and followed up for a period of not less than five years.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed breast cancer
  -  No previous interventional therapy for breast cancer
  -  Ability to provide written informed consent as per GCP and local regulations
  Exclusion Criteria:
  -  Participation in other clinical study where the diagnosis and treatment protocol is stated prior to enrolment
  -  Inability to assess and follow up patient outcomes, for example quality of life due to psychiatric illness or WHO/ECOG performance status IV or worse

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

Clinical trial: The Significance of MRI in the Development of Diagnostics and Treatment of Breast Cancer

Summary: The purpose of this study is to determine how MRI changes the treatment and diagnostics of ductal breast cancer. 100 women with newly diagnosed breast cancer will participate the study.


Eligibility: Inclusion Criteria:
  -  Tumor size less than 2cm
  -  Ductal carcinoma unifocal
  Exclusion Criteria:
  -  Previous breast cancer

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

Clinical trial: The Immune System's Response to Young Women's Breast Cancer

Summary: This study plans to learn more about the immune system's response to breast cancer in young women.

Detailed description: The investigators will be looking at the level of immune suppression in different types of breast cancer. The investigators will use blood, urine, and tissue samples from patients with Pregnancy Associated Breast Cancer (PABC) versus non-PABC, as well as comparing different types of breast cancer. If tissue sampling permits, the investigators may use some of the breast cancer tissue to develop models for human cancer for drug targeting. Understanding the immune response and suppression in different types of cancer will help us understand mechanisms involved in breast cancer better and help the investigators in developing new treatment in the future.

Eligibility: Inclusion Criteria:
  -  Females 50 or younger
  -  Histological or cytological confirmation of breast cancer
  -  Any clinical stage is allowed
  Exclusion Criteria:
  -  Any known autoimmune condition, chronic steroid use, underlying immune disease (other than breast cancer), use of immunomodulatory prescription drugs for any medical condition.
  -  The presence of other comorbid conditions known to impact immune function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe chronic obstructive pulmonary disease (COPD), uncontrolled infection or known HIV infection.)
  -  Underlying psychiatric condition which would, in the opinion of the investigator, preclude compliance with study requirements
  -  Diagnosed with another type of cancer within 5 years except for breast cancer, cervical or non-melanomatous skin cancer.

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

Clinical trial: The Psychosocial and Economic Burden of Genital Warts

Summary: Considering the importance of HPV(human papilomavirus) and related diseases in Brazil, and the lack of studies about both the economic and the psychosocial burden of these diseases, BEMFAM, a Brazilian non-governmental organization that provides reproductive health services and technical support to local governments proposes a study to measure the psychosocial and economic burden of genital warts.

Detailed description: Cervical cancer is a public health issue in Brazil. The Cancer National Institute estimates that cervical cancer will be the second most incident among women, with 18.430 new cases in 2010. Human papillomavirus (HPV) is related to cervical cancer and is also responsible for benign lesions, such as genital warts.The Brazilian Ministry of Health estimates the prevalence of genital warts to be 5,7% among pregnant women and 21,5% among women attending sexually transmitted infections treatment clinics.The study will measure the psychosocial burden of genital warts using HPV Impact Profile questionnaire and the economic burden of genital warts among women attending its six reproductive health clinics.
  There are two study objectives:
  1 - to measure the psychosocial burden of genital warts in women attending six reproductive health clinics in Brazil. 2- to measure the economic burden of genital warts treatment for women attending six reproductive health clinics in Brazil.
  Hypothesis testing:
  For objective 1, the experiment compare differences on psychosocial burden of Genital Warts among subgroups and therefore does not include any formal hypothesis testing about the psychosocial burden of the disease in agreement with the extant literature on the subject (Xingshu Zhu et al., 2009).
  Objective 2 aims to measure differentials in the economic burden of the disease among subgroups with different type of genital warts (newly diagnosed, recurrent and resistant), site of the lesion, age, duration of treatment, number of medical visits, type and number of medical procedures. No formal hypothesis will be tested.

Eligibility: Inclusion Criteria:
  -  women aged 18 to 45 years, who had a Pap-smear in the preceding 90 days or were diagnosed with genital warts during physical examination.
  -  good health
  Exclusion Criteria:
  -  women self reported HIV-positive
  -  women undergoing antiretro-viral treatment
  -  illiteracy
  -  pregnancy

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

Clinical trial: Predictive Clinical and Biological Parameters in Breast Cancer

Summary: Research of predictive clinical and biological factors in breast cancer :
  genomic, proteomic, mutation


Eligibility: Inclusion Criteria:
  -  breast cancer
  -  age > 18
  -  signed informed consent
  Exclusion Criteria:
  -  emergency

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

Clinical trial: Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité Tomos Study- Contribution of Tomosynthesis In Locoregional Pretherapeutic Staging of a Breast Tumor: Multicentricity Search

Summary: The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.

Detailed description: The secondaries objectives of the study are:
  -  Sensitivity and specificity in detecting multifocality of breast tumor
  -  Sensitivity and specificity of Tomosynthesis in the detection of contralateral tumors
  -  Predetermination of potential targets for ultrasound

Eligibility: Inclusion Criteria:
  -  Age> 18 years.
  -  Patients with a breast tumor, regardless of the stage and size
  -  Compulsory affiliation to a social security system.
  -  Obtaining informed consent in writing, signed and dated.
  Exclusion Criteria:
  -  Patients with cognitive or psychiatric disorders.
  -  Patient deprived of liberty by a court or administrative.
  -  Patients with indications against the achievement of MRI, mammography and tomosynthesis
  -  Pregnant 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: A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response

Summary: 1. Trial design: Prospective observational study
  2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria
  3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib
  -  C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
  4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )
  5. Duration of Trial Recruitment: 2 years


Eligibility: Inclusion Criteria:
  -  Informed consent
  -  19~80 year old male or female
  -  Histologically proven advanced or metastatic NSCLC
  -  Failed to 1st line chemotherapy
  -  Tumor tissue for genetic analysis
  -  Evaluable target lesion by RECIST v1.1
  -  ECOG performance from 0 to 3
  -  Expected survival more than 12 weeks
  Exclusion Criteria:
  -  Previous treatment of EGFR-tyrosine kinase inhibitors
  -  Severe hypersensitivity to erlotinib
  -  Residual toxicities (above grade 2) after previous chemotherapy
  -  Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits

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

Clinical trial: Salvage Chemotherapy of Vinorelbine Plus Oxaliplatin in Metastatic Triple-negative Breast Cancer:a Prospective Trial

Summary: The purpose of this study is to evaluate the efficacy and safety of vinorelbine plus oxaliplatin in pretreated metastatic triple-negative breast cancer.

Detailed description: Triple-negative breast cancer is associated with less treatment choices and shorter overall survival. Both vinorebine and oxaliplatin are effective in metastatic breast cancer. The investigators designed this trial to evaluate the combination of these two drugs in pretreated metastatic triple-negative breast cancer.

Eligibility: Inclusion Criteria:
  1. Females with age between 18 and 70 years old
  2. ECOG performance between 0-2
  3. Life expectancy more than 3 months
  4. Histological proven unresectable recurrent or advanced breast cancer
  5. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (IHC) test. For patients with ER negative, PR negative, Her2 two plus, a negative Her2 gene amplification should be verified with FISH test. Her2 one plus may consider FISH verification.
  6. No more than 2 chemotherapy for metastatic breast cancer.
  7. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)
  8. No anticancer therapy within 4 weeks
  9. No neuropathy more than grade I
  10. Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney
  11. Provision of written informed consent prior to any study specific procedures
  Exclusion Criteria:
  1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)
  2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study
  3. Treatment with an investigational product within 4 weeks before the first treatment
  4. Symptomatic central nervous system metastases
  5. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
  6. Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
  7. Uncontrolled serious infection
  8. Previous administration of vinorelbine
  9. Patients with bad compliance

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

Clinical trial: cKIT, BRAF/NRAS Mutations in Advanced Melanoma : Clinical Outcome in Response to Tyrosine-kinase Inhibitors - KitMel Project

Summary: Background: Metastatic melanoma has a devastating prognosis and is one of the top causes of cancer death in young patients. Until now, available therapies were few and unreliable, but recent understanding of melanomas' molecular pathways has improve their classification and new clinical strategies have been proposed.
  Initial studies showed that B-Raf/N-Ras mutations (respectively V600E and Q61) are the most frequent alteration being present in 70 to 80% of melanomas, characterizing non Chronic Sun-induced Damage skins (CSD). These include Superficial Spreading Melanomas (SSM) and Nodular Melanomas (NM). Other studies showed that c-Kit mutations are presently the predominant activating mutation (20 - 40 %) in Acro-Lentiginous Melanomas (ALM), Mucous Melanomas (MM) and in melanomas arising on CSD skin. c-Kit mutation pattern is more complex with four exons being affected leading to different mutations, which incidence and biological impact are less documented.
  BRAF/NRAS genetics alterations drive constantly cell growth, being thus attractive targets. Spectacular results have indeed been obtained with the BRAF inhibitor that targets the V600E BRAF-mutated form. Data from GIST disease revealed that the different c-Kit mutations modulate differently c-Kit function and the response to targeted therapies.
  Because c-Kit targeted therapy is a critical clinical issue, the investigators aimed to identify the most frequent mutations present in our population to propose appropriate screening test and adapt the therapy.
  Methods: 250 melanoma samples corresponding to an homogeneous white-Caucasian population (Brittany, France) will be screened. c-Kit exons 11, 13, 17 and 18 will be sequenced (direct sequencing and pyrosequencing when possible). c-Kit copy number will be quantified by q-PCR and level of c-Kit determined by immunohistochemistry (IHC, CD117). Samples will also be analyzed for B-Raf mutations in codon 464, 466, 469 and 600, and for N-Ras mutations in codon 12, 13 and 61 (Pyrosequencing).
  Expected Results:
  Taken together, the investigators anticipate that the present genetic analysis of the tumours from patients with advanced melanoma will first document the type and frequency of cKit mutations, will confirm or not that BRAF, NRAS and cKit mutations are mutually exclusive and document their repartition in the melanomas sub-types. Finally this study will clue researchers in to how well patients will respond to a therapy that targets the growth-promoting proteins BRAF/NRAS and cKIT.


Eligibility: Inclusion Criteria:
  -  melanoma
  -  white caucasian population

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

Clinical trial: Studying Blood and DNA Samples From Patients With Breast Cancer Treated With Chemotherapy With or Without Trastuzumab

Summary: RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received chemotherapy with or without trastuzumab may help doctors learn more about the effects of trastuzumab on cells. It may also help doctors understand how well patients respond to treatment.
  PURPOSE: This research trial studies blood and DNA samples from patients with breast cancer treated with chemotherapy with or without trastuzumab.

Detailed description: OBJECTIVES:
  -  To determine the role of trastuzumab in the generation of HER2-specific antibodies in breast cancer patients undergoing adjuvant combination therapy.
  -  To determine whether the improved disease-free period and overall survival of patients treated in the adjuvant setting with combination of chemotherapy and trastuzumab is dependent on the Fcγ receptor genotype of the patient.
  OUTLINE: Previously collected serum and DNA samples are analyzed for HER2-specific antibodies and FcγR genotype by enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR).

Eligibility: • Patients with HER-2-overexpressing node-positive or high-risk node-negative breast cancer enrolled on NCCTG-N9831
  * Pre- and post-treatment serum and DNA samples of patients treated with doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin®)

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 DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer

Summary: The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.

Detailed description: All women will be given two types of Jell. One should be applied immediately after radiation and the second one, 3 times every day. All women will complete detailed questionnaire every two weeks and will be evaluated by the treating team at the same time.All women will be evaluated two weeks after end of radiation period.

Eligibility: Inclusion Criteria:
  1. Woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 Gy/fx to a total dose of 50 Gy.
  2. Women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. Three weeks is the minimal interval between chemotherapy and start of radiation therapy.
  3. Patient able to understand the study designed and cooperate with instructions of use.
  4. Patient able to sign informed consent
  Exclusion Criteria:
  1. Woman with lactose allergy (lactose intolerance are eligible)
  2. Woman with known connective tissue disorder
  3. Woman with uncontrolled diabetes
  4. Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx
  5. Woman who is unable to sign an informed consent

Relevance to patient case: not relevant