Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Breast Neoplasms

Lung Neoplasms

Pelvic Neoplasms

Otorhinolaryngologic Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Head and Neck Neoplasms

Otorhinolaryngologic Diseases

Ear Nose and Throat (ENT) Cancer patients (adults)

Pediatric cancer patients (under 18 years-old) : neurologic cancer , abdomen cancer, Thorax cancer, Ear Nose and Throat (ENT) Cancer

3D maps of physical doses delivered to organs by positioning imaging will be calculated based on the patient's CT image used by the treatment planning system (dosimetric calculation performed by Monte Carlo method).

3D maps of physical doses

Alexandra BRUNEAU

Ilan Darmon

Yazid Belkacemi

Céline Berthold

Jean-Marc Cosset

Gilles Crehange

Mouna Labidi

Jean-Marc SIMON

Philippe GIRAUD, MD, PhD

Antoine Schernberg

In image-guided radiotherapy (IGRT), the repeated and increasingly intensive use of on-board positioning imaging, using 2D or 3D Mega-Volt (MV) or kilo-Volt (kV) imaging devices (cone-beam or CBCT scanners), is leading the international medical community to question the potential impact of these additional doses delivered to the patient, especially in at-risk populations such as children and young adults. The doses delivered to the patient by positioning imaging are still relatively unknown, due to the lack of experimental means and software available in clinical routine to easily and accurately evaluate these doses.

The main objective is to estimate by personalized Monte Carlo calculation the physical doses delivered to the patient's organs by the onboard imaging systems during their radiotherapy treatment. The obtained imaging doses will be compared according to different irradiation scenarios commonly used in clinical routine as well as according to the treated location.

The study will consist of 2 successive steps:

* Step 1 : for a set of patients selected in the clinical centers participating in the study, 3D maps of physical doses delivered to organs by positioning imaging will be calculated based on the patient's CT image used by the treatment planning system (dosimetric calculation performed by Monte Carlo method).
* Step 2/ all the new dosimetric data, average organ doses and dose volume histogram, will be the subject of a more global analysis, which will be returned to the project's clinical partner centers.

Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Global analysis of 3D mapping of physical doses delivered to organs by positioning imaging. These analyses will aggregate the Doses Volumes Histograms (HDV) by organs of interest as well as the mean dose to 10% (D10), 50% (D50) and 90% (D90) metrics for these same organs to form an individual dosimetric report.

Commissariat A L'energie Atomique

Assistance Publique - Hôpitaux de Paris

Behaviors and Mental Disorders

Quality of Life

Patients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device

Oncologic therapy support by means of a mobile application

mobile application

Nils Nicolay, PD Dr. Dr.

Rami A. El Shafie

The present single-center prospective exploratory study, conducted at Heidelberg University Hospital, assesses the feasibility of introducing a concept for additional patient care based on a mobile application for patients undergoing radiotherapy. Patients presenting themselves for the irradiation of thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related Quality of Life (QoL) and symptoms and their need to personally consult a physician on a treatment-daily basis by means of a mobile application. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and diagnosis-related QoL is assessed by PSQ-18 and EORTC questionnaires at the end of radiotherapy and at the first follow-up.

Single-center prospective exploratory study

Oncologic Therapy Support Via Means of a Dedicated Mobile App

Oncologic Therapy Support Via Means of a Dedicated Mobile App - a Prospective Feasibility Evaluation

Feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day

Treatment-related patient satisfaction will be assessed after therapy completion by means of the adapted PSQ-18 questionnaire.

Quality of Life will be assessed at before the start and after the completion of radiotherapy, as well as at first follow-up by means of the EORTC QLQ-C30 questionnaire and the respective diagnosis-related questionnaire modules.

Heidelberg University

PD Dr. Dr. Nils Nicolay

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients with uterine, ovarian or cervical cancers

Patients with bladder or prostate cancers

There is no intervention in this study. We will obtain faeces and blood from the recruited patients and assess the microbiota and their metabolites therein. This is an observational work

Faecal microbiota sampling and blood sampling

George Ramsay, FRCS

George Ramsay, Phd FRCS

The large intestine is the last part of the digestive tract. It absorbs water and dietary substances. However, it is also where most of our bacteria are resident. These bacteria are important for our health and influence many different diseases, including Colon Cancer, Ulcerative Colitis and Crohn's disease. The gut bacteria can also potentially influence responses to treatments in other cancers by helping to change the responses to radiotherapy and chemotherapy. The interactions between these bacteria and the rest of our cells are only now becoming understood and there is little research on the interactions between these bacteria and cancer radiotherapy treatments in pelvic cancer.

We will therefore explore this in more detail. We will ask for samples of the patient's poo before their treatment for pelvic cancers. This will include patients with bladder, prostate, cervical, ovarian, womb or colorectal cancers. By doing so we will be able to compare the profile of gut bacteria with responses to treatments, thereby increasing our understanding of the colonic bacteria.

To do this we process the poo specimens to remove the bacterial genetic material (DNA) of the bacteria and process it on a machine to read the genetic code and also study the metabolites that they will produce. We can then make a direct comparison between different samples of the relative numbers of different bacteria present. In some cases, we will compare this to metabolites and inflammatory and immune markers identified in a blood sample. This work might help future patients by determining what are the best bacteria to have in the colon during cancer treatments. These could potentially be given to patients, before their cancer treatment, in the form of probiotic medications, should there be an improvement demonstrated in our research. Alternatively we could alter the patients' intakes of specific dietary fibres to boost these bacteria specifically.

The University of Aberdeen and Aberdeen Royal Infirmary (ARI) in NHS Grampian are in the unique position of having a single site campus for microbiota-related laboratory science at the world-famous Rowett Institute, Biorepository facilities on campus for rapid sample processing and NHS facilities for treatment of multiple pelvic tumour types, including colorectal, gynaecological and urological.

Patients will be approached in their respective pelvic cancer clinics, after identification for potential inclusion at the respective multi-disciplinary team (MDT) meeting. The patient will be informed of their diagnosis and management plan by a clinician responsible for their care (may include Clinical Nurse Specialist). Patients will only be approached about the research at a subsequent meeting, e.g. when the specialist nurses contact the patient to address any further questions around the management plan discussed, they attend the consultant clinic for consent to definitive treatment, etc. This gives the patient sufficient time to process their diagnosis and management plan before introducing the research. At this meeting patients will be provided with the PIS (this will be posted to the patient if the meeting is via video teleconference). If they are willing to consider being involved, they will then be contacted by a research nurse or other suitably qualified team member, who will discuss the study further and answer any questions. If they are willing to take part arrangements will be made for a member of the clinical team to obtain written informed consent when the patient attends hospital for a subsequent clinical appointment.

They will be asked to donate a faecal sample (and in a subset of colorectal patients, a right-sided colonic contents sample taken at the time of their operation) for processing at the Rowett Institute Human Nutrition Unit before the start of their next cancer therapy (chemotherapy, radiotherapy or surgery). Consent will also be sought to obtain a blood sample. This will normally be obtained during routine venesection for clinical reasons and will be blood surplus to clinical requirements processed by the Biorepository. Where necessary, if blood is not being collected as part of standard clinical care, an extra venepuncture, of 5mls, will be requested. Blood will be processed for plasma extraction.

Patients will also be encouraged to complete an optional food frequency questionnaire (FFQ) indicating what they have eaten and drank in the three months before taking their stool samples. However, if they feel unable to complete this, their decision will be respected and they can continue in the study. These questionnaires take around 30 minutes to complete and will be provided to the patients either during a clinical appointment before their first cancer therapy or posted out to them. A subgroup of patients will also be asked if they would be willing to provide a more in-depth assessment of their diet on the four days before providing the stool sample but it will be highlighted to them that this is optional and they are free to refuse.

Faecal samples will be collected from the ARI brought to the hospital on the day of a clinic appointment or initial treatment for the patient. Alternatively, the participant can leave the sample at a specific drop off centre in the Rowett institute. This will be left to the discretion of the participant as to whichever is most convenient for them. Completed food diaries/questionnaires will also be collected at the same time and in the same location as the faecal sample drop-off.

No other additional samples are required from the patient. After obtaining the specimens, at the Rowett Institute, a portion will be processed by Dispomix for DNA extraction using Powersoil DNA extraction kits and stored in freezers before analysis by 16S rRNA gene sequencing. Another portion will be processed and stored for SCFA analysis by gas chromatography and some of the remaining faeces stored for future analyses.

Plasma will be extracted from the blood samples from the NHS Haematology laboratories and transferred to the Rowett Institute by the research team involved in the study. In situations where a blood sample has not been taken for clinical purposes the blood sample will be collected by a phlebotomist or other trained staff at the Human Nutrition unit of the Rowett Institute. Once the plasma has been extracted, the blood samples will be stored in freezers at the Rowett Institute.

16S rRNA gene sequencing of faecal DNA will be undertaken at the Centre for Genome Enabled Biology and Medicine (CCEBM), University of Aberdeen, including bioinformatics analysis. Using 16S rRNA gene sequencing, a small portion of the bacterial genetic material is examined, which differs between different bacteria, allowing us to estimate the 'relative abundance' of each within each specimen. We will also analyse SCFAs in faeces by GC and plasma by GC-MS (this more sensitive technique is required for plasma due to lower concentrations of metabolites present) at the Rowett Institute Analytical facility. At the end of this study, if sufficient sample remains in a usable condition we would like to store this for future research. After necessary funding and approvals are obtained we may in future investigate bacterial DNA in more detail (to species/strain level) by metagenomics and other metabolites, e.g. tryptophan, bile acids, and inflammatory (e.g. calprotectin) and immune markers (e.g. cytokines).

Clinical data will be pseudo-anonymised at source and collected by the research team (including biobank staff for baseline data and, research nurses, clinical fellows, radiographers, etc, for follow up data). This will be included in the subsequent analysis. Tumour responses and the side effects of radiotherapy/ chemoradiotherapy or surgery will be obtained from patient notes to look at toxicity and outcomes, and some patients will have been asked to fill in questionnaires as part of their routine clinical follow-up, such as the RTOG and EPIC26 (questionnaires routinely used in clinical practice).

16S rRNA gene sequencing data will be analysed by Bioinformaticians at the University of Aberdeen specialised in handling these large data sets, to determine the richness and relative abundance of bacteria present. Data will be stored by IT services on the High Performance Computer Cluster and submitted to a public repository. Associations will be studied between 16S rRNA gene sequencing data, SCFA analysis and available clinical data. Statistical analysis will be undertaken by Statisticians from Biomathematics and Statistics Scotland

We will undertake 16srRNA gene sequencing of the bacterial DNA, metabolite and Short Chain fatty acid analysis from the blood and faecal samples (taken from the right colon at the time of the operation). Comparisons between these microbial analysis will then be undertaken in a pair-wise approach.

Exploiting the Gut Microbiota and Its Metabolites in Pelvic Cancer

Individual participant data will be pseudo-anonymised at source and held strictly within the principles of the UK GDPR legislation. Thus, individual participant data will not be available to other researchers.

To assess if key microbes (analysed by pyrosequencing), or their metabolic byproducts (analysed by short chain fatty acid identification) detect for positive or adverse response to conventional therapy and cancer outcomes

16srRNA pyrosequencing and short chain fatty acid analysis will be undertaken for patients with the three cancer groupings. These data will be compared against each other to assess similarity or differences in the faecal microbial flora between the conditions.

University of Aberdeen

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Nervous System Diseases

Prostatic Neoplasms

Pain, Postoperative

Urinary Bladder Neoplasms

Pain

Urologic Neoplasms

Postoperative Complications

Neurologic Manifestations

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Central Nervous System Depressants

Analgesics

Bupivacaine

Ropivacaine

Morphine

Hydromorphone

Analgesics, Opioid

Narcotics

The treatment group will have pre-operative ultrasound-guided single shot bilateral rectus sheath blocks with 20 ml of a ropivacaine / bupivacaine mixture per side.

The control group will have a pre-operative sham ultrasound-guided subcutaneous injection of 1ml saline per side.

Rectus sheath block

A nerve block catheter known as a continuous rectus sheath block is inserted by the surgeon at the end of the operation. An infusion of 0.2% ropivacaine is delivered through this for up to 48 hours post-operatively.

Bilateral rectus sheath catheter

Patients in both groups will have PCA dilaudid or morphine prescribed for the post-operative period.

Patient controlled opioid analgesia (PCA)

Subcutaneous injection of 1ml of normal saline under ultrasound guidance at the same site bilaterally as rectus sheath blockade is performed

Subcutaneous injection saline placebo

Objectives The primary objective is to demonstrate that in patients undergoing major urologic surgery, Patient Controlled Analgesia (PCA) opioid consumption in the first 24 hours after surgery will be significantly less in patients who have had a single shot rectus sheath block pre-operatively in addition to a post-operative rectus sheath continuous block via surgically placed catheter versus those who only have post-operative rectus sheath continuous block. Secondary outcomes will be opioid requirement intra-operatively, Numerical Rating Scale (NRS) pain scores including maximum pain score in Post Anesthesia Care Unit (PACU) and score at 24 and 48 hours, incidence and severity of nausea, number of vomiting episodes, sedation score, time to first bowel movement, time to first mobilization and duration of hospital stay.

Purpose: To improve analgesia and reduce opioid consumption in patients undergoing major urologic surgery.

Hypothesis: Patients receiving pre-operative single shot rectus sheath blockade in addition to continuous rectus sheath catheters will use less PCA opioid in the first 24 hours post-operatively compared to patients receiving continuous rectus sheath blockade for major urologic surgery.

Justification:

The sensorimotor innervation of the anterior abdominal wall is supplied by the ventral rami of the thoracolumbar spinal (T7-L1) segmental nerves. The thoracolumbar nerves course along the anterolateral wall within the transversus abdominis plane (TAP), and continue anteromedially, before entering the lateral aspect of the posterior rectus sheath. The nerves provide both muscular and cutaneous branches to innervate the muscle fibers and overlying skin with innervation from both left and right nerves supplying the midline. Regional anesthesia techniques for the anterior abdominal wall include both TAP and rectus sheath blocks.

The TAP block has been investigated extensively and shown to reduce opioid analgesia requirements post-operatively. The main difference between TAP block and rectus sheath block is that the rectus sheath block targets the nerves at a more anterior location. Bilateral rectus sheath nerve blocks are required to provide cover for midline incision and the investigators have previously described rectus sheath block with nerve catheter insertion under ultrasound guidance for midline laparotomy. A recent retrospective review from Dutton et al on the use of rectus sheath catheters for major urologic surgery reported that they offer an effective and safe method of peri-operative analgesia in patients undergoing major open urological pelvic surgery. Tudor et al demonstrated that rectus sheath catheters provide analgesia equivalent to that provided by epidurals following laparotomy for colorectal surgery.

At the University of Alberta Hospital, patients having major urologic surgery e.g. cystectomy have surgically placed rectus sheath catheters sited at the end of the procedure as a standard of analgesia care. This is combined with patient-controlled analgesia (PCA) opioid as part of a multimodal approach to post-operative pain control.

One disadvantage of surgically placed TAP and rectus sheath catheters is that they are inserted at the end of surgery. Therefore, the patient does not benefit from them intra-operatively and other methods of analgesia including opiates are required to reduce the sympathetic response to surgical stimulation and to prevent excessive immediate and early post-operative pain. The surgically placed rectus sheath catheters are sited during wound closure and then bolused with local anesthetic just prior to emergence so often the block is not fully established in the early post-operative period resulting in further opiate analgesia requirement.

The primary objective is to demonstrate that in patients undergoing major urologic surgery PCA opioid consumption in the first 24 hours after surgery will be significantly less in patients who have had an ultrasound-guided single shot rectus sheath block pre-operatively in addition to a post-operative rectus sheath continuous block via surgically placed catheter versus those who only have post-operative rectus sheath continuous block.

Secondary outcomes will be opiate requirement intra-operatively, Numerical Rating Scale (NRS) pain scores including pain score in PACU and score at 24 and 48 hours, incidence and severity of nausea, number of vomiting episodes, sedation scores, time to first bowel movement, time to first mobilization and duration of hospital stay.

Research Methods: A randomized, double-blinded controlled trial.

Subjects who meet eligibility criteria will be invited to participate in the study by the clinical care team or research assistant in the Preadmission Clinic. Informed consent will be obtained by the research assistant. Next, all eligible participants will be randomized to the treatment group i.e. pre-operative single shot bilateral rectus sheath blocks + post-operative catheters or the control group i.e. post-operative catheters.

Randomization will be conducted through stratified-blocked randomization with varying blocks of 4 to 6 according to a schedule not known to the investigators using a computerized algorithm. The patient, intra-operative anesthetist, the surgeon and the assessor will be blinded to the randomization assignment.

The treatment group will have pre-operative single shot bilateral rectus blocks with 20 ml of a ropivacaine / bupivacaine mixture per side. The control group will have a pre-operative sham subcutaneous injection of 1ml saline per side. Both groups will have bilateral rectus sheath catheters placed surgically at the end of the procedure. Under direct visualization, the surgeon will insert a standard nerve block catheter between the rectus abdominis muscle and the posterior rectus sheath lateral to the incision on both sides. The catheter will be fixed to skin via a specialized taping system. An infusion of 0.2% ropivacaine will be administered through the rectus sheath catheter (1ml / hour continuous infusion with 15 ml /hour bolus every 4 hours). All patients will receive an IV morphine or dilaudid PCA and adjunctive post-operative medication. Intra-operative morphine / dilaudid administered intra-operatively will be recorded as well as total morphine / dilaudid used in the first 24 hours. Anesthesia technique will be standardized for short-acting opioid use i.e. fentanyl. Peri-operative multimodal analgesia adjuncts will include ketamine 0.2mg/kg and dexamethasone 6mg. All patients will be pre-medicated with acetaminophen 1g and gabapentin 300mg pre-operatively.

Primary and secondary outcomes will be collected by the study team from the patient chart and accompanying records and through patient interview. Continuous variables will be analyzed using t-tests and categorical variables will be analyzed using chi-squared test.

The intra-operative anesthesiologist, surgeon and outcomes assessor are blinded to group allocation

Pre-Operative Single Shot Rectus Sheath Block

Measuring the Analgesic Effect of Adding Pre-Operative Single Shot Rectus Sheath Blocks to Post-Operative Rectus Sheath Continuous Blocks for Major Urologic Surgery: A Randomized Controlled Trial

Opioid requirement in first 24 hours after surgery

Surgery times vary but on average the procedure being investigated takes 3 - 6 hours. Opioid administered during this time by the intra-operative anesthesiologist will be recorded for the study.

The NRS pain scale is a used to measure pain intensity. Patients are asked to rate their pain between 0 (no pain) and 10 (worst pain possible)

Rated as mild, moderate or severe by the patient

Number of discrete vomiting episodes per 24 hour period

Name and total dose of anti-emetic per 24 hour period

Patients will be rated as alert, drowsy, light sedation i.e. awakens with eye contact), moderate sedation (wakens to voice), deep sedation (wakes to physical stimulation but not to voice) and unrousable (no response to voice or physical stimulation).

Time from end of surgery to first bowel movement.

Time from end of surgery to sitting on chair by bed

Time from end of surgery to ready for discharge

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests	NCT05258383	Lung Neoplasm Pelvic Neoplasm Breast Cancer Cancer, Otorhin... Cancer Pediatri...	3D maps of phys...	-	Assistance Publique - Hôpitaux de Paris
Oncologic Therapy Support Via Means of a Dedicated Mobile App	NCT03168048	Thoracic Neopla... Pelvic Neoplasm Radiotherapy; C... Oncologic Disor... Breast Cancer Satisfaction Quality of Life	mobile applicat...	18 Years -	Heidelberg University
Exploiting the Gut Microbiota and Its Metabolites in Pelvic Cancer	NCT05605353	Pelvic Neoplasm	Faecal microbio...	16 Years - 99 Years	University of Aberdeen
Pre-Operative Single Shot Rectus Sheath Block	NCT03458598	Bladder Neoplas... Prostate Neopla... Pelvic Neoplasm Urologic Neopla... Opioid Use Anesthesia, Loc... Pain, Postopera...	Rectus sheath b... Bilateral rectu... Patient control... Subcutaneous in...	18 Years -	University of Alberta

Spots Global Cancer Trial Database for pelvic neoplasm