Clinical trials: Organ Preservation
Cancer of Larynx
Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
The purpose of this study is to learn how to identify early which patients will respond to chemotherapy plus radiation therapy in order to reduce the number of subjects who require surgery (followed by radiation therapy).
- Trial name
- NCT00599131
- Testing
- Cisplatin, Cetuximab, 5-Fluorouracil
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Michigan Rogel Cancer Center
End Stage Liver DIsease
Comparison of Hypothermic Versus Normothermic Ex-vivo Preservation.
Study groups: The study is a multicenter (Pisa and Milan), prospective, randomized study comparing D-HOPE (HMP) vs NMP in DCD and ECD-DBD (extended criteria brain-dead donors).
- Trial name
- DCDNet (NCT04744389)
- Testing
- Hypothermic Machine Perfusion, Normothermic Machine Perfusion
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
Organ Preservation
A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation
This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to…
- Trial name
- OPTIMAL (NCT06263023)
- Testing
- Sub-Normothermic Machine Preservation and Assessment
- Where
- 8 sites in United States
- Volunteers
- 80 people
- Sponsor
- 34 Lives, PBC
RECTAL NEOPLASMS, Rectal Cancer
Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study
This is an open-label, multi-center, single-arm clinical study. All patients received concurrent chemoradiation therapy (CRT) followed by 4 cycles of tislelizumab combined with CAPOX, then underwent clinical response assessment.
- Trial name
- NCT06390982
- Testing
- Radiotherapy, Tislelizumab, Capecitabine
- Volunteers
- 46 people
- Sponsor
- Fudan University
Rectal Cancer, Radiation Oncology
Higher Radiation Dose to the Tumor May Help Avoid Surgery in Rectal Cancer Patients
The goal of this prospective study is to evaluate if a higher radiation dose to the tumor can increase the organ preservation rate in non-locally advanced rectal cancer.
- Trial name
- REBOOT (NCT07616297)
- Testing
- Simultaneous integrated boost to the tumor and positive mesorectal lymph nodes
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Claudia Schuurhuizen
Malignant Colorectal Polyp, Colorectal Cancer
A Prospective Registry of Patients With Endoscopically Resected Malignant Colorectal Polyps (pT1 Colorectal Cancer)
The purpose of this study is to learn more about malignant colorectal polyps (early colorectal cancers removed during colonoscopy) and the risk that cancer remains, comes back, or spreads after the polyp is removed.
- Conditions
- Malignant Colorectal Polyp, Colorectal Cancer, T1 Colorectal Cancer
- Trial name
- NCT07619079
- Testing
- Questionnaires
- Where
- 7 sites in United States
- Volunteers
- 500 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Organ Preservation Solution
Machine Perfusion in High vs Low/Mid-volume Liver Transplant Centers: a Multicentre Survey
Introduction: Machine perfusion (MP) was developed to expand the available donor pool and to improve liver transplantation outcomes.
- Trial name
- MP-LTx (NCT05662969)
- Testing
- MACHINE PERFUSION
- Where
- Italy
- Volunteers
- 67 people
- Sponsor
- Roberta Angelico
Organ Preservation, Liver Transplantation
Long-term Outcomes After Hypothermic Oxygenated Machine Perfusion of Donor Livers Using Real-world Data
End-ischemic hypothermic oxygenated machine perfusion (HOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary…
- Conditions
- Organ Preservation, Liver Transplantation, Hypothermic Machine Perfusion
- Trial name
- HOPE-REAL (NCT05520320)
- Testing
- Hypothermic oxygenated machine perfusion (any device)
- Where
- 2 sites in Netherlands, Switzerland
- Volunteers
- 1,202 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Lung Preservation
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).
- Trial name
- INSPIRE (NCT01630434)
- Testing
- OCS Lung, Cold flush and storage
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 320 people
- Sponsor
- TransMedics
Rectal Cancer, Rectum Neoplasm
Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment
Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery.
- Trial name
- LORENA (NCT05927584)
- Testing
- Transanal local excision
- Where
- Spain
- Volunteers
- 145 people
- Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Rectal Cancer
An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer
The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design…
- Trial name
- NCT04443543
- Testing
- Capecitabine (Xeloda) Pharmacogenetic Test Reagents, irinotecan, IMRT
- Where
- China
- Volunteers
- 222 people
- Sponsor
- Fudan University
Organ Transplantation From Brain-dead Donors
Cooling to Optimize Organ Life in Donor Study
The purpose of this study is to assess the feasibility and safety of mild-to-moderate hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60 brain-dead organ donors.
- Trial name
- COOLDonor (NCT01544530)
- Testing
- Cold isotonic fluid and central venous hypothermia catheter
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Pittsburgh
Rectal Adenocarcinoma, Rectal Cancer
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
Rectal cancer patients who do not achieve a complete response to standard of care chemotherapy and radiation often require surgical resection as part of curative intent therapy.
- Trial name
- NCT07292298
- Testing
- High Rare Dose Rectal Brachytherapy Boost
- Where
- 3 sites in United States
- Volunteers
- 44 people
- Sponsor
- University of Colorado, Denver
Chronic Kidney Disease, Acute Kidney Injury
FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.
This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with acute kidney injury (AKI).
- Trial name
- NCT01978314
- Testing
- 75 mg / 6 mL VFI™
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- FAST BioMedical
Heart Transplantation, Graft Rejection
ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study
The goal of this observational study is to evaluate whether molecular analysis of donor heart biopsies taken at the time of organ removal ("Time Zero") can help predict the future function and rejection risk of the transplanted…
- Conditions
- Heart Transplantation, Graft Rejection, Myocardial Injury, Organ Preservation
- Trial name
- ZeroHeart (NCT06982404)
- Testing
- Time Zero Donor Heart Biopsy for Molecular Analysis
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Medical University of Vienna
Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation and Continuing Response
This phase II/III trial compares the effect of usual treatment approach alone (FOLFOX or CAPOX after chemoradiation) with using FOLFIRINOX after chemoradiation in patients with stage II-III rectal cancer.
- Conditions
- Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Locally Advanced Rectal Adenocarcinoma
- Trial name
- JANUS (NCT05610163)
- Testing
- Capecitabine, 5-fluorouracil, Leucovorin calcium
- Where
- 685 sites in United States, Puerto Rico
- Volunteers
- 760 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Transplant; Failure, Heart
A Randomized Controlled Trial Comparing Non-ischemic to Ischemic Preservation in Adult Cardiac Transplantation
The overall aim of this proposal is to compare a new state-of-the-art ex-vivo organ preservation method with standard ischemic cold static storage of donor hearts in adult cardiac transplantation.
- Trial name
- NIHP (NCT03150147)
- Testing
- Non-ischemic preservation, Ischemic cold static storage
- Where
- Sweden
- Volunteers
- 47 people
- Sponsor
- Region Skane
Esophageal Cancer
A Multicenter Phase II Clinical Study of Neoadjuvant Use of Camrelizumab in Combination With Chemotherapy for Organ Preservation in Esophageal Cancer
This is a multicenter phase II clinical study to explore the efficacy, safety, and organ preservation feasibility of camrelizumab in combination with chemotherapy for resectable esophageal squamous carcinoma in patients with…
- Trial name
- NCT06869226
- Testing
- Camrelizumab + Nab-paclitaxel + Cisplatin
- Where
- China
- Volunteers
- 283 people
- Sponsor
- Peking University Cancer Hospital & Institute
Liver Transplantation, Liver Preservation for Transplant
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
- Trial name
- PROTECT (NCT02522871)
- Testing
- OCS™ Liver System, Control
- Where
- 20 sites in United States
- Volunteers
- 300 people
- Sponsor
- TransMedics
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer.
- Conditions
- Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8
- Trial name
- NCT04703101
- Testing
- Capecitabine, Fluorouracil, Intensity-Modulated Radiation Therapy
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Jonsson Comprehensive Cancer Center