araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 32-year-old male with melanoma; genetic feature: NRAS (Q61H)

Clinical trial: Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission (QUALM)

Summary: Few studies have been conducted on the quality of life of patients with stage IV melanoma. Particularly, there is no data regarding the quality of life of patients with a multimetastatic melanoma currently in remission.
  Then, the main objective of this study is to evaluate the quality of life from a point of view medico-psycho-social in patients with multimetastatic melanoma in remission for more than 6 months.

Detailed description: The cutaneous melanoma, (9th rank of all cancers), was until recently neglected and poorly known by the general public. The metastatic stages have dramatic rates of survival: 25% at 1 year and 2% at 5 years with a median of about 6.2 months. However, in the last ten years, the treatment of metastatic forms has undergone a real revolution.
  Its high metastatic potential for a very low initial tumor mass, gives evidence of a great aggressiveness. The cutaneous melanoma is resistant to the main therapeutics (chemotherapy and radiotherapy). Thanks to the emergence of immunotherapies and targeted therapies anti-RAF (Rapidly Accelerated Fibrosarcoma) and anti-MEK (Mitogen-activated Extracellular) the prognosis of patients with metastatic melanoma has considerably improved, increasing the number of "long-term survivors".
  However, these treatments can cause many adverse effects that can impact patients' quality of life, despite a better tolerance compared to conventional chemotherapies. To our knowledge there are no data regarding the quality of life of patients with metastatic melanoma currently in remission.For this purpose, it is necessary to obtain solid data using validated questionnaires. Thus, we have chosen to evaluate quality of life using specific questionnaires to better understand patients' expectations, their difficulties, and then to improve the relationship between the patient and the physician.

Eligibility: Inclusion Criteria:
  -  Adult patients
  -  Presenting a stage IV melanoma of the American Joint Committee on Cancer (AJCC) classification (multimetastatic) in remission for more than 6 months:
  -  Complete remission (defined as the complete disappearance of target lesions according to the RECIST criteria, based on a thoraco-abdomino-pelvic CT scan and a brain Magnetic resonance imaging (MRI) or
  -  Complete metabolic remission (defined as the complete disappearance of target lesions in PET CT (positron emission tomography computed tomograph, that is to say, disappearance of the hypermetabolic character of the anatomic structures. There may remain target lesions in conventional CT but they are not hypermetabolic in PET CT)
  -  Patients able to answer the questionnaires
  -  Patients with enough understanding of the French language
  Exclusion Criteria:
  -  Adjuvant treatment
  -  Patient under tutorship or curatorship
  -  Refusal to participate in the study

Relevance to patient case: not relevant
Patient case: 32-year-old male with melanoma; genetic feature: NRAS (Q61H)

Clinical trial: Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK

Summary: The therapeutic arsenal of metastatic melanoma has changed considerably over the past 10 years. The treatment of metastatic melanoma is now based on immunotherapy and targeted therapies, while the place of conventional chemotherapy becomes more restricted. Targeted therapies are indicated for BRAF mutated melanomas.
  The mutation BRAF leads activation of MAP Kinases pathway and the proliferation of melanoma cell in the body . About 50% of metastatic melanoma is BRAF mutated. The most frequent mutation is the V600E. The targeted therapy by anti BRAF and anti MEK allows the double bloking of the MAP Kinases pathway. This treatment is more efficient than that of the anti BRAF alone. The association of anti BRAF and anti MEK have a global survival global rate of 41% at the 1 year, against 9% for the anti BRAF .
  In 2014, a program of extended access to the association of anti BRAF and anti MEK (dabrafenib and trametinib) started in many french hospitals (Protocol Mekinist, Novartis laboratory). Patients who were included in this program and followed in Poitiers Hospital, had frequent abnormalities of albumin level without any sign of undernutrition.
  Hypoabuminemia is a poor prognosis factor described in many cancers, including metastatic melanoma.
  The only prognostic factor in metastatic melanoma is the rate of LDH . The level of albumin and its prognostic impact have not been studied for patients with a metastatic melanoma and treated by anti BRAF and anti MEK.
  The objective of this studie was to analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated in our Center by dabrafenib and trametinib


Eligibility: Inclusion Criteria:
  -  Age > 18 ans
  -  the patients with unresecable stage IIIc or IV melanoma with BRAF V600 E or K mutation,
  -  treated by dabrafenib and trametinib by the program of extended access (research protocol Mekinist)
  Exclusion Criteria:
  -  Age < 18 ans
  -  patients who had less than 3 months of treatment,
  -  patients for which the albumin level could not be carried out before starting treatment, and after the first month

Relevance to patient case: not relevant
Patient case: 32-year-old male with melanoma; genetic feature: NRAS (Q61H)

Clinical trial: Predicting Response to Immunotherapy for Melanoma With Gut Microbiome and Metabolomics

Summary: This study will investigate the effects of gut microbiome diversity (richness in terms of many bacterial species in the gut) on responses and side effects of immunotherapy in advanced melanoma patients. Immunotherapy for melanoma is especially damaging for the gut with colitis which can lead to death and significant morbidity with repeated hospital admissions. The richness of the microbiome in the gut may be protective against colitis and other side effects but this needs to be confirmed. There is also some preliminary evidence that the gut microbiome diversity can enhance responses to immunotherapy in cancer but this has been shown in small numbers of melanoma patients.

Detailed description: This pilot project will assess the gut microbiome with metagenome sequencing before and after starting immunotherapy in stage 4 melanoma patients. The project will assess the impact of the gut microbiome on treatment response rates and side effects induced by immunotherapy. 160 stage 4 melanoma patients naive to immunotherapy will be recruited from the melanoma clinic at Mount Vernon Cancer Centre (part of East and North Hertfordshire NHS Trust) as well as Guy's and St Thomas' NHS Foundation Trust and UCLH NHS Foundation Trust. 80 cases will be recruited at Mount Vernon Cancer Centre and 40 cases at Guy's and St Thomas' Foundation Trust and UCLH respectively. Stool samples will be donated pre-treatment and at three follow up visits at 3 weekly intervals until week 9.An additional sample will also be requested in the event of disease progression. An accompanying stool sample questionnaire will be completed at each sampling time point with the optional completion of a 24-hour recall food diary.
  Blood samples will also be taken at week 0 and week 3 with gastrointestinal, food frequency, quality of life questionnaires administered at baseline. The microbiome data from melanoma patients will be compared with the TwinsUK healthy control gut microbiome data on more than 3000 healthy adults. This analysis will help us assess if there are major differences between the microbiome composition in the melanoma cases prior to therapy compared to the control gut microbiome data from TwinsUK.

Eligibility: Inclusion Criteria:
  - Patients aged over the age of 18 years with stage 4 melanoma due to receive first line systemic treatment with immunotherapy with a checkpoint inhibitor alone or in combination.
  Exclusion Criteria:
  -  Patients who have had systemic anti-cancer treatment for locally advanced or metastatic disease.
  -  Patients unable to consent because of language barrier or inability to consent.
  -  Patients unable to collect or send the stool samples for geographical, social or psychological reasons.
  -  Persons benefitting from protection system of adults (including guardianship and curatorship)
  -  Pregnant or breastfeeding women

Relevance to patient case: not relevant
Patient case: 32-year-old male with melanoma; genetic feature: NRAS (Q61H)

Clinical trial: Folfirinox + Cetuximab Chemotherapy, in First Line, With Wild RAS and According to BRAF Status in Metastatic Colorectal Cancer

Summary: This retrospective study, will evaluate patient outcomes after triplet chemotherapy (FOLFIRINOX) (5 Fluorouracil + oxaliplatin + irinotecan) plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS (KRAS, NRAS (neuroblastoma rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.

Detailed description: In Europe, there are 447,000 new cases of colorectal cancer each year. Approximately 25% of patients present with metastases at initial diagnosis and almost 50% of patients with mCRC (metastatic colorectal cancer) will develop metastases
  . Chemotherapy represents the backbone of treatment, and survival is linked with the administration of all three active cytotoxic agents (5-fluorouracil/folinate, oxaliplatin, and irinotecan) in the first line treatment of metastatic colorectal disease.
  Monoclonal antibodies such as cetuximab in combination with chemotherapy are a first line treatment option in metastatic RAS (rat sarcoma viral oncogene homolog) wild type metastatic colorectal cancer (mCRC).
  Phase II trials evaluating triplet chemotherapy plus cetuximab reported interesting results in terms of efficacy (response rate, resectability...), but at the price of an increased rate of toxic effects.
  This retrospective study, will evaluate patient outcomes after triplet chemotherapy (FOLFIRINOX) (5 Fluorouracil + oxaliplatin + irinotecan) plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS (KRAS, NRAS (neuroblastoma rat sarcoma viral oncogene homolog) wild-type mCRC (metastatic colorectal cancer) population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.

Eligibility: Inclusion Criteria:
  1. Colorectal cancer confirmed as RAS wild by tumor tissue analysis
  2. Non resectable and measurable metastatic disease
  3. Patients treated with FOLFIRINOX + cetuximab in first line metastatic disease
  4. Males or females aged over 18 years.
  Exclusion Criteria:
  1. Known brain metastases
  2. RAS not assessable (e.g., material not available or insufficient)
  3. The first administration of cetuximab was more than 30 days after the first administration of FOLFIRINOX
  4. History of other malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane

Summary: This study is a Phase IV, prospective, nonrandomized, community-based study of clinical outcomes in patients with metastatic breast cancer treated with Herceptin and a taxane.


Eligibility: Inclusion Criteria:
  -  Signed informed consent
  -  Available tissue for central laboratory evaluation of HER2 status
  -  Histologically confirmed, measurable or nonmeasurable but evaluable, HER2 positive metastatic breast cancer (HER2 positive is defined as 3+ staining by IHC or gene amplification by FISH, determined by the local or central laboratory)
  -  Life expectancy >6 months
  -  Female, age >=18 years
  -  ECOG performance status of 0, 1, or 2
  -  Adequate bone marrow function as indicated by the following: *ANC >1500/uL, *Platelet count >=100,000/uL
  -  Adequate renal function, as indicated by creatinine <=1.5× upper limit of normal (ULN)
  -  Adequate liver function, as indicated by bilirubin <=1.5× ULN and AST or ALT <2× ULN unless related to primary disease
  -  Use of an adequate means of birth control (women of childbearing potential)
  Exclusion Criteria:
  -  Initiation of Herceptin >=4 weeks after beginning taxane chemotherapy
  -  Prior chemotherapy for metastatic disease
  -  Prior cumulative anthracycline dose of >360 mg/m2
  -  History of significant cardiac disease or uncontrolled arrhythmias
  -  Ejection fraction of <50% or below the lower limit of normal
  -  Active infection
  -  Symptomatic or untreated brain metastases
  -  Pregnancy or lactation
  -  Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  -  Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
  -  Hypersensitivity to study medications
  -  Major organ failure or systemic disease precluding the safe administration of study medications

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer

Summary: RATIONALE: Studying quality-of-life in patients undergoing cancer treatment may help identify the intermediate and long-term effects of treatment on patients with cancer.
  PURPOSE: This clinical trial is studying quality of life in patients who are receiving either vinorelbine, gemcitabine, and docetaxel or paclitaxel and carboplatin for advanced non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Compare the quality of life of patients with advanced non-small cell lung cancer treated with vinorelbine, gemcitabine, and docetaxel vs paclitaxel and carboplatin on protocol JMTO-LC00-03.
  OUTLINE: This is a multicenter study. Patients receive treatment on protocol JMTO-LC00-03.
  Quality of life is assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L), FACT-Taxane, and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) questionnaires at baseline, weeks 9 and 18, and at the completion of treatment.
  PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed primary non-small cell lung cancer, including any of the following:
  -  Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease
  -  Newly diagnosed stage IV disease
  -  Recurrent disease after prior surgery and/or radiotherapy
  -  Any of the following cellular subtypes are allowed:
  -  Adenocarcinoma
  -  Large cell carcinoma
  -  Squamous cell carcinoma
  -  Unspecified carcinoma
  -  Enrolled on protocol JMTO-LC00-03
  PATIENT CHARACTERISTICS:
  Performance status
  -  Zubrod 0-1
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Radiotherapy
  -  See Disease Characteristics
  Surgery
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Summary: This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen


Eligibility: Inclusion Criteria:
  -  Patients with locally advanced/metastatic non-small cell lung cancer
  -  Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen
  Exclusion Criteria:
  -  Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
  -  History of or known brain metastases

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC

Summary: This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.


Eligibility: Inclusion Criteria:
  -  Age >= 18
  -  Histologically or cytologically documented non-small cell lung cancer (NSCLC)
  -  Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
  -  Radiologically measurable or evaluable disease No prior chemotherapy
  -  1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
  -  Tumor tissue block or fine needle aspirate
  Exclusion Criteria:
  -  Any concurrent anticancer therapy or radiation
  -  Other active malignancy
  -  Uncontrolled brain metastases
  -  GI abnormalities
  -  Severe abnormalities of the cornea
  -  Significant cardiac disease
  -  Active infection

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases

Summary: This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.


Eligibility: Inclusion Criteria:
  -  Patients with radiologically proven brain metastases secondary to non-small cell lung cancer
  -  Received previous whole brain radiation therapy and none, 1 or 2 prior systemic therapy for the treatment of advanced/metastatic non-small cell lung cancer
  Exclusion Criteria:
  -  Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or leptomeningeal disease.
  -  Brain metastases >4 cm in any linear direction
  -  Intracranial or intratumoral hemorrhage

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Summary: This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.


Eligibility: Inclusion Criteria:
  -  adult patients >=18 years of age;
  -  histologically documented, locally advanced , recurrent or metastatic NSCLC;
  -  measurable disease;
  -  no disease progression after 4 cycles of platinum-based chemotherapy.
  Exclusion Criteria:
  -  unstable systemic disease;
  -  any other malignancies in the last 5 years.

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions

Summary: The purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.

Detailed description: Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.

Eligibility: Inclusion Criteria:
  -  Colorectal adenocarcinoma, Wild KRAS, 18-75 yr
  -  Estimated life expectancy of more than 3 months
  -  ECOG performance status of 0 to 1 at study entry
  -  Adequate bone marrow function
  -  Adequate liver function
  -  Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy
  -  Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit
  -  Informed Consent
  Exclusion Criteria:
  -  Central nervous system (CNS) metastases or prior radiation for CNS metastases.
  -  Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
  -  Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study.
  -  Evidence of gastrointestinal bleeding
  -  Exposure to Cetuximab
  -  Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment
  -  KRAS mutant Status
  -  Patients with serious toxicity to previous irinotecan-based chemotherapy
  -  Other serious illness or medical conditions

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the CARNEY Complex (CNC)

Summary: Cohort CNC-PPNAD will be investigated with clinical, genetic, biological and imaging work-up every year during 3 years. Cohort L-MC will be investigated clinically at inclusion and a PERKAR1A genotype will be performed.

Detailed description: The primary aim is to assess the clinical manifestations of the CARNEY Complex (CNC) and/or the primary pigmented nodular adrenocortical disease (PPNAD) in patients with CNC, isolated PPNAD or carriers of PRKAR1A and PPNAD1 (PDE11A4) germline mutation (Cohort CNC-PPNAD). In this cohort genotype/phenotype correlation will be studied. A second aim is to determine the frequency of PRKAR1A germline mutation in patients with isolated cardiac myxoma or isolated lentiginosis (Cohort L-MC).

Eligibility: Inclusion Criteria:
  CNC group :
  -  patient with the CARNEY complex (CNC) or the primary pigmented nodular adrenocortical disease (PPNAD) or a germinal mutation of the gene of CARNEY Complex or PPNAD.
  -  No age criteria
  -  Inform consent of the patient or the parental authority collected
  -  Realization of a preliminary medical examination
  -  Affiliated with a social security system ( profit or having right)
  MC-L group :
  -  Patient with periorificial lentiginosis or cardiac myxoma
  -  or previous history of periorificial lentiginosis or cardiac myxoma
  -  age > or = 18 years old
  -  Realization of a preliminary medical examination
  -  Affiliated with a social security system ( profit or having right)
  Exclusion criteria :
  CNC group and MC-L group:
  -  refusal or incapacity to take part in the study

Relevance to patient case: not relevant