20ml of blood only one thoracocentesis (the same that one for diagnostic)

blood sample, thoracocentesis

Patrice Roll

Accurate characterization of malignant cells obtained via thoracocentesis is of paramount importance in the management of cancer patients. The identification of novel biomarkers may in that regard considerably improve the diagnostic approach of these pleural effusions, guide therapeutic decisions, particularly with respect to targeted therapies, and offer helpful prognostic information. Nuclear anomalies represent the cornerstone of the cytologic and/or histopathologic diagnosis of malignant cells. The nuclear matrix is a fundamental constituent of the nuclear architecture via its interaction with the nuclear membrane, but is also directly involved with DNA and RNA processing. Prior studies have suggested that in some cancers, the lamins, a major constituent of the nuclear matrix, have different patterns of expression or nuclear localization that could potentially have prognostic implications. Our project aims at studying the constituents of the nuclear matrix of malignant cells isolated for pleural fluid in patients with metastatic disease, both of bronchogenic or non-bronchogenic origin, which, to our knowledge, has not yet been done. Both proteomic (localization by immunofluorescence and expression by Western-Blot) and genomic (microarray, CGH type) analyses will be undertaken to identify microrearrangements in the genes of interest. The primary aim is to identify specific biomarkers to more accurately characterize malignant cells in metastatic pleural disease.

Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis

Research for quantitative or qualitative nuclear-matrix-proteins anomalies in secondary metastatic pleural disease and/or for anomalies in the genes coding for these proteins.

Protein analysis : immunofluorenscy, western blot. Genomic analysis : CGH arrays.

by taking account of the origin and the histological nature of the primitive tumor

the tumoral cells genome versus the peripheral cells genome

Showing differences between tumor cells, cell-lineages and cells released in the liquid

Assistance Publique Hopitaux De Marseille

Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance.

The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance

ccfDNA analysis

Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect recurrences or metastases, a surveillance strategy is recommended for patients able to withstand complementary treatment during a five-year period. Over this period, the probability of one false-positive result is 87%. Considering that less than 10% of recurrent patients are suitable for potentially curative treatment and that more intensive programs enable an increase of the overall rate of curative resection but do not result in reduced mortality, less time and cost-consuming, tailored follow-up is necessary. The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance.

Tubes for ccfDNA analysis will be taken during medical examination at the same time of the CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for analysis in the laboratory INSERM (National Health Institute) of Montpellier and the remaining plasma will be kept in biological collection.

Patients will have a consultation of follow-up every 3-4 months during which the dosage of CEA and ccfDNA will be realized as well as a medical examination, a general examination (weight, size, and blood pressure), an evaluation of the indices of performance status and a nutritional evaluation in case of loss of weight.

Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment

University Hospital, Limoges

Symptoms and General Pathology

Nervous System Diseases

Pain

Pain, Procedural

Neurologic Manifestations

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Psychotropic Drugs

Anesthetics

Nitrous Oxide

Anesthetics, Local

Analgesics, Opioid

Lidocaine, Prilocaine Drug Combination

Anti-Anxiety Agents

30 patients will be included in the virtual reality arm

30 patients will be included the usual practices

In each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the the RV group, The session will be started before the gesture and the patient will wear the helmet throughout the act. In case of pain and / or restlessness, the child will receive analgesics.

Virtual Reality

In each arm, patients will benefit from an EMLA-type local anesthetic cream, pain and anxiety assessment. During the act, the physiological constants will be recorded (Fr, O2 and pulse). In the control group, the child will receive the usual care: nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine

Usual Practices

Amandine AF FERNANDES

Karine KG ESTEVE-GARNIER

Amandine FERNANDES

This pilot study will be testing the feasibility of medical hypnosis through virtual reality during invasive médical procédures in children with cancer. Patients age from 7 to under 18 years whose treatement protocols required a lumbure puncture and a chemotherapy by implantable venous access will be randomly assigned to virtual reality or treatement as usual (nitrous oxide, anxiolytics, opioid analgesics, psychotropic and benzodiazepine). We expect the same benefit by using VR as usual intervention.

Nationally, around 2,150 new cases of cancer are diagnosed per year in children aged 0 to 18. The main locations are leukemia, central system tumors and lymphomas. The onco-pediatrics unit of the Poitiers University Hospital is recruiting around 70 patients per year from 0 to under 18 years old. 1482 invasive procedures have been done in 2019. The diagnostic and therapeutic methods for these children remain aggressive and involve patients in chronic care. They repeatedly undergo painful and anxiety-inducing care. In pediatrics, nitrous oxide is chosen as the first-line choice in these various procedures, but its effectiveness is not always conclusive, due to habituation, and can induce side effects. For some children, it becomes difficult to obtain their consent to care, despite the range of different analgesics offered, and forces prescribers to increase the drugs. Virtual reality (VR) has already been shown to be effective on pain and anxiety in children and adolescents. This devices uses distraction and hypnosis techniques by establishing a state of hypnosedation and mediation through the work of breathing and sophrology. With this study, we expect the same benefit by using VR as usual pratices.

After explaining the treatment protocol, the potentially eligible patient will be informed by the investigator of the possibility of participating in this clinical trial. After checking the eligibility criteria and including the patient, the investigator can randomize the patient in the control group or the experimental group. As part of this study, patients will be followed for 1 month and for each act of lumbar puncture and connection to an implantable chamber.

This is an exploratory interventional, comparative, single-center, randomized research into 2 parallel groups. The study will compare the use of virtual reality versus usual practices for two iterative and painful acts: lumbar puncture and connection to an implantable chamber.

Impact of Virtual Reality in Pediatric Hematology and Oncology

Impact of Virtual Reality in Pediatric Hematology and Oncology for the Management of Pain During Invasive Procedures in Children 7 to Under 18 Years in a Pilot Study

At the inclusion, the primary endpoint will be to assess pain using the Visual Analogue Scale (VAS) after the first invasive act of lumbar puncture or connection to an implantable chamber.

The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The EVA (Analogue Visual Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain.

The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment:

* 0: no pain
* Between 1 and 3: mild pain
* Between 3 and 5: moderate-intensity pain
* Between 5 and 7: severe pain
* Greater than 7: very intense pain

Pain from the VAS after the 1st connection to the implantable chamber:

The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain.

The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment:

* 0: no pain
* Between 1 and 3: mild pain
* Between 3 and 5: moderate-intensity pain
* Between 5 and 7: severe pain
* Greater than 7: very intense pain

The Frankl scale, is a scale of hetero-evaluation of anxiety. It will be performed by the caregiver before the invasive procedure (lumbar puncture and connection to an implantable chamber). It is suitable for children from 7 to under 18 years old and is easy to score:

* 0: Definitely negative behavior; refuses treatment, shouts forcefully, opposes/cares,
* 1: Negative behavior: unwilling to accept care; unwilling to accept care. Some signs of opposition exist but not necessarily declared (sullen air, scowling),
* 2: Positive behaviour; accepts treatment with reservation. He is cautious but follows the instructions of the practitioner/caregiver
* 3: Definitely positive behavior; good relations/practitioner/caregiver, interested in treatment. He laughs often and seems to enjoy the visit/care.

The type of associated analgesics, the dosage will be collected through the patient's medical record

Heart rate (min \<40 B/min - max \>200 B/min), from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)

oxygen saturation (min \<90% - max \>100%) from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)

Respiratory rate (min \<10 - max \> 50) from a scope connected to the patient before and throughout the duration of the invasive act (lumbar puncture and / or connection to an implantable chamber)

Tolerance, in number of episodes of confusion, agitation, dizziness, nausea, vomiting, headache, hallucinations and temporary amnesia during the performance of the invasive act and within 2 hours of post-act monitoring for a lumbar puncture and 30 minutes for a connection to an implantable chamber

A patient may have several consecutive invasive acts. The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7:

* 0: no pain
* Between 1 and 3: mild pain
* Between 3 and 5: moderate-intensity pain
* Between 5 and 7: severe pain
* Greater than 7: very intense pain

Pain from the VAS after the 1st connection to an implantable chamber the :

The pain assessment will be carried out using a Visual Analogue Scale provided as part of the clinical investigation.The VAS (Visual Analogue Assessment) from 0 to 10, is a scale that can be used from the age of 7. It reliably allows self-assessment of pain.

The scale will be explained to the child before the act and it will be presented to him after the invasive act for the assessment:

* 0: no pain
* Between 1 and 3: mild pain
* Between 3 and 5: moderate-intensity pain
* Between 5 and 7: severe pain
* Greater than 7: very intense pain

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nuclear Matrix and Cancer: Proteomic and Genomic Analyses Using Microarray in Cells Obtained Via Thoracocentesis	NCT01284777	Cancer	blood sample, t...	18 Years -	Assistance Publique Hopitaux De Marseille
Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment	NCT02813928	Colorectal Canc...	ccfDNA analysis	18 Years -	University Hospital, Limoges
Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment	NCT02813928	Colorectal Canc...	ccfDNA analysis	18 Years -	University Hospital, Limoges
Impact of Virtual Reality in Pediatric Hematology and Oncology	NCT05275881	Virtual Reality Pediatrics Cancer Pain Procedural Pain	Virtual Reality Usual Practices	7 Years - 17 Years	Poitiers University Hospital
Impact of Virtual Reality in Pediatric Hematology and Oncology	NCT05275881	Virtual Reality Pediatrics Cancer Pain Procedural Pain	Virtual Reality Usual Practices	7 Years - 17 Years	Poitiers University Hospital
Impact of Virtual Reality in Pediatric Hematology and Oncology	NCT05275881	Virtual Reality Pediatrics Cancer Pain Procedural Pain	Virtual Reality Usual Practices	7 Years - 17 Years	Poitiers University Hospital

Spots Global Cancer Trial Database for cancerology

Every month we try and update this database with for cancerology cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cancerology

Every month we try and update this database with for cancerology cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cancerology cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.