araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)

Summary: National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed colorectal cancer
  2. KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
  3. Non resectable metastatic disease in a curative intent
  4. No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment earlier than 6 months ago from inclusion date
  5. Patient presenting with at least one measurable tumour target (greater than 20 mm) according to RECIST criteria, which has never been irradiated
  6. Patient with a greater than 3 month life expectancy
  7. Performance Status less or equal to 2
  8. Male or female 18 years or older
  9. Acceptable blood test
  10. Patient who has signed a written informed consent form
  Exclusion Criteria:
  1. Known and/or symptomatic brain metastases
  2. Known allergy to one of treatment components
  3. Neurological or psychiatric condition which could interfere with good treatment compliance
  4. Patient currently in treatment with any other anti-tumour therapy: chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
  5. Other serious conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  6. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrolment/randomisation
  7. Concomitant severe infection.
  8. History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
  9. Patient already included in another clinical trial with an investigational molecule
  10. Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)
  11. Pregnant female, likely to be or currently breast feeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
  12. Those deprived of their freedom or under guardianship
  13. Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)

Summary: Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma patients carrying a reasonable risk for metastases. In numerous studies the prognostic role of micro metastases in the sentinel node (SN) was described. However, the prognostic value of a complete lymph node dissection in patients with a positive SN is still unclear.
  This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.


Eligibility: Inclusion Criteria:
  -  Cutaneous melanoma with a tumour thickness of at least 1,00mm
  -  Positive sentinel node with micro metastases of max. 2mm in diameter
  Exclusion Criteria:
  -  Mucosal or ocular melanoma
  -  Cutaneous melanoma located in the head/neck region
  -  Evidence of satellite, in transit or local metastases / recurrences
  -  Macro metastases of the SN or micro metastases of >2mm in diameter
  -  Additional immune-suppressive therapy
  -  Pregnant of lactating women

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: Videoscopic Ilioinguinal Lymphadenectomy for Melanoma

Summary: Groin lymph node dissection for melanoma patients is burdened by high post-operative morbidity, mainly related to wound. This is a prospective pilot trial investigated feasibility and postoperative outcomes of videoscopic ilioinguinal lymphadenectomy in patients with inguinal lymph node melanoma metastases.

Detailed description: Videoscopic ilioinguinal dissection is a two-stage procedure. Dissection is performed using an ultrasound dissector. The inguinal step is performed via three ports (one 3-5 cm above the apex of the femoral triangle, a second 5 cm medial to the adductors, and the third 5 cm lateral to the Sartorius muscle). After subcutaneous inflation, a formal inguinal lymph node (LN) dissection is performed, removing the contents of the femoral triangle, with incision and removal of the femoral fascia and proximal and distal ligation of the saphenous vein with vascular endostaplers and endoclips. The specimen is extracted using an endobag from the incision of SLNB, which is systematically removed, or through a small enlargement of the incision of the apex trocar for patients with clinically positive LNs. The iliac step starts with open insertion in the pro-peritoneal space of a Hasson trocar, followed by positioning of two additional trocars (5 and 10 mm respectively) just laterally of the umbilical pubic line. After creation of pneumo-pelvis, the iliac femoral vessels are identified, isolated and all the external iliac LNs removed. Afterwards, the obturator LNs are dissected off the obturator nerve. LNs are retrieved with an endobag or directly through the 10mm trocar after insertion of protective endotrocar. Two drains are positioned at the end of procedure in the obturator fossa and in the inguinal space, respectively. Intra-operative and early post-operative outcome (lenght of stay, complications, number of LNs) is recorded. Follow-up consists in detection of any recurrence, measurement of lymphedema of the leg and evaluation of quality of life

Eligibility: Inclusion Criteria:
  Melanoma patients without distant metastasis and either positive SLNB or clinically positive inguinal lymph nodes
  Exclusion Criteria:
  American Society of Anaesthesiologists (ASA) classification III-IV Severe chronic obstructive pulmonary disease (COPD) and other restrictive lung disease, Severe ischemic heart disease and chronic heart failure Previous cerebral abnormalities (aneurysm/arteriovenous malformations, ischemic/hemorrhagic stroke, primary or secondary tumors), History of deep vein thrombosis (DVT) Childbearing state Severe hip functional limitation Previous hip/knee arthroplasty. Previous surgery in the groin region (e.g., hernia repair, great saphenous vein surgery, iliac-femoral bypass) was considered a contraindication only for the iliac stage of lymphadenectomy.

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: Application of Genomic Techniques and Image Processing Using Artificial Intelligence to Obtain a Predictor Model Risk of Melanoma

Summary: The aim of this study is to develop a predictive model of risk of developing melanoma. The investigators will used artificial intelligence techniques to analysed images patterns obtained by clinical and dermoscopic pictures. The investigators want to defined a new predictive risk model obtained from genetic information and image analysis of pigmented lesions. This model could help to discriminate more accurately those patients who are most likely to develop melanoma in a high-risk population.


Eligibility: Inclusion Criteria:
  -  ≥18 years of age;
  -  Followed up patients in the Pigmented Lesions Unit at Reina Sofia University Hospital with high risk of developing melanoma (First-degree family/personal history of familiar melanoma and/or melanocyticnevi above 50 and/or dysplastic or atypical nevi);
  -  All nevi for which there is at least one dermatoscopy registry will be included.
  Exclusion Criteria:
  -  not enough data in the patient clinical history;
  -  located lesions on the face, scalp, mucous membrane or on acral área;
  -  nodular or metastatic melanoma diagnosis
  -  type V or VI of Fitzpatrick phototyping scale

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma

Summary: This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.


Eligibility: Inclusion Criteria:
  -  Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
  -  Written informed consent granted
  Exclusion Criteria:
  - Do not fulfill one or more inclusion criteria

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer

Summary: RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.

Detailed description: The study will be proposed to all patients with a metastatic colorectal cancer.
  Study information will be given to the patient during a routine medical examination. The patient will be included after checking inclusion criteria and signature of the informed consent form
  Blood sampling (30 ml) will be performed before the initiation of the first line metastatic chemotherapy.

Eligibility: Inclusion Criteria:
  -  Adult subjects with newly diagnosed, anti EGFR treatment naïve metastatic colorectal cancer
  -  Standard of Care RAS/RAF tests performed on FFPE tumor sample as part of routine
  -  Patient information and written informed consent form signed
  -  Patient must be affiliated to a social security system
  -  Age : 18 years and older
  Exclusion Criteria:
  -  Patient bearing non-metastatic colorectal cancer
  -  Patient with local relapse only
  -  Patient with exclusive nodal metastases
  -  Patient whose health contraindicates a 30 ml blood sample
  -  Blood transfusion within 1 week prior blood collection
  -  Patient having received any chemotherapy or / and radiotherapy within 15 days prior to blood collection
  -  History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix
  -  Persons deprived of liberty or under supervision

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: The ED50 of DEX for Providing Sedation in Different Female Age Group

Summary: Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age, and current studies with regard to the effects of age on dexmedetomidine pharmacodynamic are rare. This study was designed to explore the right DEX dose of different female Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of sedation for patients is also investigated.

Detailed description: 90 patients scheduled for combined spinal epidural spinal anesthesia were included in one of three groups. In each group,determination of median effective (ED50) doses was performed by the Dixon up-and-down method, an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1 μg/kg in first three turning points and 0.05μg/kg in the last three turning points.Initial doses was 1.4μg/kg, .Sedative efficacy was defined as an OAA/S of ≤3,30 min after the beginning of drug administration.

Eligibility: Inclusion Criteria:
  1. ASA Ⅰ ~ Ⅱ patient undergoing lower extremity surgery
  2. Written informed consent from the patient or the relatives of the participating patient.
  3. BMI:18.0～25.0kg/m2
  Exclusion Criteria:
  1. Mental illness can not match
  2. epidural anesthesia contraindicated
  3. People who have Slow-type arrhythmias
  4. People who were language or hearing impaired
  5. Sensory block reached to T8 or higher.
  6. People who had lung infection or sleep apnea syndrome.
  7. Pregnancy
  8. Chronic renal failure
  9. Alcohol or drug abuse
  10. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer

Summary: The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin


Eligibility: Inclusion Criteria:
  -  Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation
  -  Age ≥ 18 years
  -  Patient information and written informed consent form signed
  -  Patient must be affiliated to a social security system
  Exclusion Criteria:
  -  Patients whose health-cons indicates a blood sample 10mL
  -  Age < 18 years
  -  Pregnant or breast feeding females
  -  Persons deprived of liberty or under supervision

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: Registry for Acute Pain Treatment

Summary: The German Network for acute pain management and Regional Anesthesia (NRA) is a multi-center, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported procedural and outcome data of systemic analgesia and regional anesthesia hosted by the German Society of Anesthesia and Intensive Care Medicine (DGAI) and professional Society German Anesthetists (BDA)

Detailed description: NRA offers the systematic documentation of patient related and procedure related components for acute pain treatments during and after surgery.
  NRA collects preoperative, intraoperative, and postoperative data from treating physicians who complete a standard form. Data are collected concurrently with patient care by pain nurses or treating physicians and include detailed information about the medical conditions of patients having acute pain treatment along with the procedure and postoperative course.
  The registry provides the basis for large scale analyses and benchmarks for several parameters.
  The registry also aims at performing population-based research. Furthermore, its infrastructure allows for the conduct of prospective studies comparing the effectiveness of processes of care.

Eligibility: Inclusion Criteria:
  -  The investigators include anonymous data from patients with continuous regional anesthesia, single shot regional anesthesia, or systemic analgesia
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)

Summary: Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up

Detailed description: The ct DNA R0 study is a prospective, open labelled, monocentric trial. The aim is to evaluate the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up.
  The patient will have a blood sample before and after the surgery and during the post-surgery follow-up. The patient will have a maximum of 10 blood samples during the 2 years of his follow-up of the study.

Eligibility: Inclusion Criteria:
  1. Aged 18 years old or more
  2. Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).
  3. No other distant metastasis (CT thoracic -abdomino -pelvic, bone scan).Measurable metastatic disease (echography, CT and/or MRI, FDG-PET, (fluoro- D-glucose integrated with computed tomography)).
  4. Patient able to stand a blood collection.
  5. Patient explanation given and consent information signed or by legal representative.
  Exclusion Criteria:
  6. Patient without social protection / insurance..
  7. Patient with hepatic metastasis unresectable by surgery
  8. Patient with extra-hepatic metastasis.
  9. Person deprived of liberty or under guardianship
  10. Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

Summary: Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.
  In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.

Detailed description: The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood.
  The secondary objectives of this study will be:
  -  Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma.
  -  Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA

Eligibility: Inclusion Criteria:
  -  patient with melanoma confirmed histologically
  -  patient with metastatic melanoma (stage III unresectable or stage IV)
  -  patient consenting to participate to the study
  -  patient enrolled in the national healthcare insurance program
  -  patient older than 18 years
  Exclusion Criteria:
  - Metastatic tumor whose origin is doubtful (uncertain melanoma)

Relevance to patient case: not relevant
Patient case: 63-year-old female with melanoma; genetic feature: NRAS (Q61R)

Clinical trial: A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma

Summary: The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic KIT-mutated melanoma.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Unresectable stage III or stage IV melanoma which is histologically confirmed at the treating institution with KIT mutation(s) not known to be resistant to PLX3397
  -  Presence of measurable lesions by Response Evaluation Criteria in Solid Tumors
  -  Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-2
  -  Life expectancy ≥ 3 months
  -  Adequate organ and bone marrow function
  -  Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drug. Women of non-child-bearing potential must have been postmenopausal for ≥ 1 year or surgically sterile.
  -  Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug.
  -  Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements
  Exclusion Criteria:
  -  Prior treatment with a KIT inhibitor for melanoma
  -  Presence of NRAS or BRAF mutation
  -  Exposure to any investigational drug within 28 days or unresolved adverse effects from previous therapy
  -  Symptomatic brain metastases.
  -  Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Sponsor
  -  Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable)
  -  Uncontrolled intercurrent or infectious illness
  -  Major surgical procedure or significant traumatic injury within 14 days of initiating study drug or anticipation of the need for major surgery during the study
  -  Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 28 days prior to study entry
  -  Inability to swallow capsules, or refractory nausea and vomiting, malabsorption, an external biliary shunt, or significant bowel resection that would preclude adequate absorption
  -  Congestive heart failure (CHF) New York (NY) Heart Association class III or IV; unstable coronary artery disease (myocardial infarction [MI] more than 6 months prior to study entry is permitted); or serious cardiac arrhythmia
  -  Baseline QTcF ≥ 450 msec (for males) or ≥ 470 msec (for females) at Screening
  -  Active or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
  -  Known chronic liver disease
  -  Women who are breast-feeding or pregnant

Relevance to patient case: not relevant