Kidney Transplant RejectionTTIPSNCT05335538
TruGraf and TRAC In Pediatrics Study
An observational study of Kidney Transplant Rejection, run by Transplant Genomics, Inc. at 3 sites in 2 countries.
Trial summary
This is a pilot 3 center prospective study of pediatric renal kidney recipients undergoing protocol biopsies examining the performance of the TruGraf gene expression test in children and adolescents. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Patients monitored with TruGraf and TRAC testing
- How many people
- 75 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Nov 2021to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Renal transplant pediatric patients age 1 to 18 years old who must be undergoing a protocol biopsy.
Who may be able to join
- Patients aged 1-≤ 18 years and recipients of either living or deceased donor transplants Undergoing a protocol biopsy at either 3, 6, 12, 24 or 36 months
- Serum creatinine at the time of the clinic visit prior to the scheduled biopsy within 30% of a baseline calculated as the mean of the recipient's last 3 serum creatinine levels
- Serum creatinine level at the time of protocol biopsy ≤ 1.7 mg/dl.
- Patient receiving immunosuppression with a calcineurin inhibitor (either tacrolimus or cyclosporine) and/or an antimetabolite (either mycophenolate mofetil, mycophenolic acid EC or azathioprine) and/or an mTOR inhibitor (either sirolimus or everolimus) and/or corticosteroids.
- Absence of any systemic or urinary bacterial, viral or fungal infection
- Absence of significant BK viremia (as determined by the laboratory where the determination is run) at the time of the last clinical determination and at the time of the protocol biopsy
- Parents or guardians are capable of reading and understanding the Informed Consent document and willing to participate; if appropriate, patient is also able to understand the Informed Consent. If patient is older than 13 years, patient should be able to give Assent as written on Assent Form.
- For females of child-bearing age, a negative pregnancy test within 6 weeks of the protocol biopsy.
Who cannot join
- Refusal to undergo clinical standard-of-care protocol biopsy by either parent/guardian or patient.
- Inability to obtain adequate tissue on protocol biopsy
- Current participation in another interventional research study; patients who have completed the drug in another interventional study are eligible if they meet all other inclusion criteria.
- Serum creatinine at the clinic visit prior to the biopsy is > 30% of a baseline calculated as the mean of the recipient's last 3 serum creatinine levels.
- Serum creatinine at the time of the protocol biopsy ≥ 1.8 mg/dl. If the patient had a baseline < 1.8, and the creatinine on the day of biopsy is ≥ 1.8, at the discretion of the PI, the patient will be instructed to hydrate for 4 days and a serum creatinine will be obtained at that time. This is standard clinical practice. If the creatinine returns to the baseline (i.e., ≤ 30%) range, the patient will be classified as having stable renal function, while if the patient's serum creatinine does not return to the ≤ 30% range, he/she will be classified as having renal dysfunction
- Patients who, in the estimation of the investigator, are undergoing "for-cause" biopsies.
Show all 14Show fewer
- Presence of any current and active bacterial, viral or fungal infection
- Presence of BK viremia judged to be significant by the site PI.
- Presence of BK nephropathy
- History of PTLD or malignancy
- Parents / guardians do not understand Informed Consent and / or are unwilling to participate; patient, if of appropriate age, is unwilling to participate
- Patients manifesting recurrent disease in their transplant (such as FSGS/nephrotic syndrome, C3 Glomeruopathy, MPGN, hyperoxaluria)
- Abnormal proteinuria as determined by a urinary protein: creatinine ratio of >1.
- Recipients of multi-organ transplants.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Michael Seifert, MD, mseifert@peds.uab.edu
- Recruiting
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Robert Ettenger, MD, REttenger@mednet.ucla.edu
Canada1 site, 1 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver
Tom Blydt-Hansen, MD, tom.blydthansen@cw.bc.ca
About this study
Official title: The Role of TruGraf® to Optimize Outcomes in Pediatric Renal Transplantation
This is a pilot 3 center prospective study of pediatric renal kidney recipients undergoing protocol biopsies examining the performance of the TruGraf gene expression test in children and adolescents.
Read the detailed description
In pediatric renal transplant recipients, subclinical rejection in protocol biopsies is associated with a significantly increased incidence of acute rejection and/or allograft loss at 5 years post-transplant. Currently, TruGraf is the only noninvasive test designed and validated in adult kidney transplant recipients for use in ruling out silent subacute rejection in that has been approved by Medicare as an alternative to surveillance biopsies. The first step to the use of TruGraf in pediatrics is to perform a validation study in children and adolescents. Specifically, if validated in children and adolescents, a TruGraf result would enable a pediatric transplant physician to identify patients in whom no intervention is necessary without the need of a protocol biopsy. Therefore the aim of this study is to examine the concordance between the results of the TruGraf tests and protocol biopsies taken from stable pediatric renal transplant patients concurrently.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Patients monitored with TruGraf and TRAC testing
- Keywords
- Biomarkers, Subclinical Rejection, Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients monitored with TruGraf and TRAC testingDiagnostic test
This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of Biomarkers with protocol biopsy
Examination of the concordance between the results of the TruGraf tests and protocol biopsies taken from stable pediatric renal transplant concurrently.
Measured: 1 year
Secondary outcomes (6)
Concordance between the results of the TruGraf test and the histological finding of borderline changes vs. TCMR vs. AMR.
Separately examine the concordance between the results of the TruGraf test and the histological finding of borderline changes vs. TCMR vs. AMR.
Measured: 1 year
Compare TruGraf results in patients ≤ 11 years old vs ≥ 12 years old
Compare the agreement between protocol biopsies and TruGraf results in patients ≤ 11 years old vs ≥ 12 years old
Measured: 1 year
Relationship between de novo DSA, a normal protocol biopsy and the TruGraf result.
Assess the relationship, if any, between the appearance of de novo DSA, a normal protocol transplant biopsy and the TruGraf result.
Measured: 1 year
Examine TruGraf results and the %CV tacrolimus levels- index of medication nonadherence.
Examine the relationship between the TruGraf results and the %CV tacrolimus levels as an index of medication nonadherence.
Measured: 1 year
Relationship between urinary CXCL10 and subclinical rejection affecting the predictive value of TruGraf.
Examine the relationship between urinary CXCL10 and subclinical rejection in this patient cohort to examine whether it improves the performance metrics by improving the negative or positive predictive of TruGraf.
Measured: 1 year
Examine relationship between ddcfDNA and subclinical rejection
Examine the relationship between ddcfDNA and subclinical rejection in this patient cohort
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start30 Nov 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (62)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transplant Genomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham, University of British Columbia, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Patty West-Thielke, PharmD, Study director, Transplant Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335538
- Sponsor's protocol ID
- TGRP08
- Acronym
- TTIPS
- Status last verified
- Aug 2021
- First submitted
- 12 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moudgil A, Dharnidharka VR, Lamb KE, Meier-Kriesche HU. Best allograft survival from share-35 kidney donors occurs in middle-aged adults and young children-an analysis of OPTN data. Transplantation. 2013 Jan 27;95(2):319-25. doi: 10.1097/TP.0b013e3182719203.
PubMed 23154211Horslen S, Barr ML, Christensen LL, Ettenger R, Magee JC. Pediatric transplantation in the United States, 1996-2005. Am J Transplant. 2007;7(5 Pt 2):1339-58. doi: 10.1111/j.1600-6143.2007.01780.x.
PubMed 17428284Verghese PS. Pediatric kidney transplantation: a historical review. Pediatr Res. 2017 Jan;81(1-2):259-264. doi: 10.1038/pr.2016.207. Epub 2016 Oct 12.
PubMed 27732587United States Renal Data System 2018 Annual Data Report Volume 2 ESRD Chapter 5
Aubert O, Loupy A, Hidalgo L, Duong van Huyen JP, Higgins S, Viglietti D, Jouven X, Glotz D, Legendre C, Lefaucheur C, Halloran PF. Antibody-Mediated Rejection Due to Preexisting versus De Novo Donor-Specific Antibodies in Kidney Allograft Recipients. J Am Soc Nephrol. 2017 Jun;28(6):1912-1923. doi: 10.1681/ASN.2016070797. Epub 2017 Mar 2.
PubMed 28255002Ettenger R, Albrecht R, Alloway R, Belen O, Cavaille-Coll MW, Chisholm-Burns MA, Dew MA, Fitzsimmons WE, Nickerson P, Thompson G, Vaidya P. Meeting report: FDA public meeting on patient-focused drug development and medication adherence in solid organ transplant patients. Am J Transplant. 2018 Mar;18(3):564-573. doi: 10.1111/ajt.14635. Epub 2018 Jan 25.
PubMed 29288623Birk PE. Surveillance biopsies in children post-kidney transplant. Pediatr Nephrol. 2012 May;27(5):753-60. doi: 10.1007/s00467-011-1969-8. Epub 2011 Jul 27.
PubMed 21792611Gordillo R, Munshi R, Monroe EJ, Shivaram GM, Smith JM. Benefits and risks of protocol biopsies in pediatric renal transplantation. Pediatr Nephrol. 2019 Apr;34(4):593-598. doi: 10.1007/s00467-018-3959-6. Epub 2018 May 3.
PubMed 29725772Nazario M, Nicoara O, Becton L, Self S, Hill J, Mack E, Evans M, Twombley K. Safety and utility of surveillance biopsies in pediatric kidney transplant patients. Pediatr Transplant. 2018 Jun;22(4):e13178. doi: 10.1111/petr.13178. Epub 2018 Mar 27.
PubMed 29582530Rush D. Protocol biopsies should be part of the routine management of kidney transplant recipients. Pro. Am J Kidney Dis. 2002 Oct;40(4):671-3. doi: 10.1053/ajkd.2002.36427. No abstract available.
PubMed 12324898Rose EM, Kennedy SE, Mackie FE. Surveillance biopsies after paediatric kidney transplantation: A review. Pediatr Transplant. 2016 Sep;20(6):748-55. doi: 10.1111/petr.12733. Epub 2016 Jun 16.
PubMed 27306873Birk PE, Stannard KM, Konrad HB, Blydt-Hansen TD, Ogborn MR, Cheang MS, Gartner JG, Gibson IW. Surveillance biopsies are superior to functional studies for the diagnosis of acute and chronic renal allograft pathology in children. Pediatr Transplant. 2004 Feb;8(1):29-38. doi: 10.1046/j.1397-3142.2003.00122.x.
PubMed 15009838Furness PN, Philpott CM, Chorbadjian MT, Nicholson ML, Bosmans JL, Corthouts BL, Bogers JJ, Schwarz A, Gwinner W, Haller H, Mengel M, Seron D, Moreso F, Canas C. Protocol biopsy of the stable renal transplant: a multicenter study of methods and complication rates. Transplantation. 2003 Sep 27;76(6):969-73. doi: 10.1097/01.TP.0000082542.99416.11.
PubMed 14508363Nankivell BJ, Agrawal N, Sharma A, Taverniti A, P'Ng CH, Shingde M, Wong G, Chapman JR. The clinical and pathological significance of borderline T cell-mediated rejection. Am J Transplant. 2019 May;19(5):1452-1463. doi: 10.1111/ajt.15197. Epub 2019 Jan 22.
PubMed 30501008Seifert ME, Yanik MV, Feig DI, Hauptfeld-Dolejsek V, Mroczek-Musulman EC, Kelly DR, Rosenblum F, Mannon RB. Subclinical inflammation phenotypes and long-term outcomes after pediatric kidney transplantation. Am J Transplant. 2018 Sep;18(9):2189-2199. doi: 10.1111/ajt.14933. Epub 2018 Jun 27.
PubMed 29766640
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of TruGraf® to Optimize Outcomes in Pediatric Renal Transplantation
- ClinicalTrials.gov ID
- NCT05335538
- Acronym / sponsor ID
- TTIPS / TGRP08
- Conditions
- Kidney Transplant Rejection
- Keywords
- Biomarkers, Subclinical Rejection, Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Transplant Genomics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham, University of British Columbia, University of California, Los Angeles
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot 3 center prospective study of pediatric renal kidney recipients undergoing protocol biopsies examining the performance of the TruGraf gene expression test in children and adolescents.
Detailed description
In pediatric renal transplant recipients, subclinical rejection in protocol biopsies is associated with a significantly increased incidence of acute rejection and/or allograft loss at 5 years post-transplant. Currently, TruGraf is the only noninvasive test designed and validated in adult kidney transplant recipients for use in ruling out silent subacute rejection in that has been approved by Medicare as an alternative to surveillance biopsies. The first step to the use of TruGraf in pediatrics is to perform a validation study in children and adolescents. Specifically, if validated in children and adolescents, a TruGraf result would enable a pediatric transplant physician to identify patients in whom no intervention is necessary without the need of a protocol biopsy. Therefore the aim of this study is to examine the concordance between the results of the TruGraf tests and protocol biopsies taken from stable pediatric renal transplant patients concurrently.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Renal transplant pediatric patients age 1 to 18 years old who must be undergoing a protocol biopsy.
Key inclusion criteria (8 listed)
- Patients aged 1-≤ 18 years and recipients of either living or deceased donor transplants Undergoing a protocol biopsy at either 3, 6, 12, 24 or 36 months
- Serum creatinine at the time of the clinic visit prior to the scheduled biopsy within 30% of a baseline calculated as the mean of the recipient's last 3 serum creatinine levels
- Serum creatinine level at the time of protocol biopsy ≤ 1.7 mg/dl.
- Patient receiving immunosuppression with a calcineurin inhibitor (either tacrolimus or cyclosporine) and/or an antimetabolite (either mycophenolate mofetil, mycophenolic acid EC or azathioprine) and/or an mTOR inhibitor (either sirolimus or everolimus) and/or corticosteroids.
- Absence of any systemic or urinary bacterial, viral or fungal infection
Key exclusion criteria (14 listed)
- Refusal to undergo clinical standard-of-care protocol biopsy by either parent/guardian or patient.
- Inability to obtain adequate tissue on protocol biopsy
- Current participation in another interventional research study; patients who have completed the drug in another interventional study are eligible if they meet all other inclusion criteria.
- Serum creatinine at the clinic visit prior to the biopsy is > 30% of a baseline calculated as the mean of the recipient's last 3 serum creatinine levels.
- Serum creatinine at the time of the protocol biopsy ≥ 1.8 mg/dl. If the patient had a baseline < 1.8, and the creatinine on the day of biopsy is ≥ 1.8, at the discretion of the PI, the patient will be instructed to hydrate for 4 days and a serum creatinine will be obtained at that time. This is standard clinical practice. If the creatinine returns to the baseline (i.e., ≤ 30%) range, the patient will be classified as having stable renal function, while if the patient's serum creatinine does not return to the ≤ 30% range, he/she will be classified as having renal dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients monitored with TruGraf and TRAC testingThis is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management. | Diagnostic test | – |
Primary outcome
Concordance of Biomarkers with protocol biopsy
Time frame: 1 year
Examination of the concordance between the results of the TruGraf tests and protocol biopsies taken from stable pediatric renal transplant concurrently.
6 secondary outcomes
Concordance between the results of the TruGraf test and the histological finding of borderline changes vs. TCMR vs. AMR.
Time frame: 1 year
Compare TruGraf results in patients ≤ 11 years old vs ≥ 12 years old
Time frame: 1 year
Relationship between de novo DSA, a normal protocol biopsy and the TruGraf result.
Time frame: 1 year
Examine TruGraf results and the %CV tacrolimus levels- index of medication nonadherence.
Time frame: 1 year
Relationship between urinary CXCL10 and subclinical rejection affecting the predictive value of TruGraf.
Time frame: 1 year
Examine relationship between ddcfDNA and subclinical rejection
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background: PubMed 23154211Moudgil A, Dharnidharka VR, Lamb KE, Meier-Kriesche HU. Best allograft survival from share-35 kidney donors occurs in middle-aged adults and young children-an analysis of OPTN data. Transplantation. 2013 Jan 27;95(2):319-25. doi: 10.1097/TP.0b013e3182719203.
- Background: PubMed 17428284Horslen S, Barr ML, Christensen LL, Ettenger R, Magee JC. Pediatric transplantation in the United States, 1996-2005. Am J Transplant. 2007;7(5 Pt 2):1339-58. doi: 10.1111/j.1600-6143.2007.01780.x.
- Background: PubMed 27732587Verghese PS. Pediatric kidney transplantation: a historical review. Pediatr Res. 2017 Jan;81(1-2):259-264. doi: 10.1038/pr.2016.207. Epub 2016 Oct 12.
- BackgroundUnited States Renal Data System 2018 Annual Data Report Volume 2 ESRD Chapter 5
- Background: PubMed 28255002Aubert O, Loupy A, Hidalgo L, Duong van Huyen JP, Higgins S, Viglietti D, Jouven X, Glotz D, Legendre C, Lefaucheur C, Halloran PF. Antibody-Mediated Rejection Due to Preexisting versus De Novo Donor-Specific Antibodies in Kidney Allograft Recipients. J Am Soc Nephrol. 2017 Jun;28(6):1912-1923. doi: 10.1681/ASN.2016070797. Epub 2017 Mar 2.
- Background: PubMed 29288623Ettenger R, Albrecht R, Alloway R, Belen O, Cavaille-Coll MW, Chisholm-Burns MA, Dew MA, Fitzsimmons WE, Nickerson P, Thompson G, Vaidya P. Meeting report: FDA public meeting on patient-focused drug development and medication adherence in solid organ transplant patients. Am J Transplant. 2018 Mar;18(3):564-573. doi: 10.1111/ajt.14635. Epub 2018 Jan 25.
- Background: PubMed 21792611Birk PE. Surveillance biopsies in children post-kidney transplant. Pediatr Nephrol. 2012 May;27(5):753-60. doi: 10.1007/s00467-011-1969-8. Epub 2011 Jul 27.
- Background: PubMed 29725772Gordillo R, Munshi R, Monroe EJ, Shivaram GM, Smith JM. Benefits and risks of protocol biopsies in pediatric renal transplantation. Pediatr Nephrol. 2019 Apr;34(4):593-598. doi: 10.1007/s00467-018-3959-6. Epub 2018 May 3.
- Background: PubMed 29582530Nazario M, Nicoara O, Becton L, Self S, Hill J, Mack E, Evans M, Twombley K. Safety and utility of surveillance biopsies in pediatric kidney transplant patients. Pediatr Transplant. 2018 Jun;22(4):e13178. doi: 10.1111/petr.13178. Epub 2018 Mar 27.
- Background: PubMed 12324898Rush D. Protocol biopsies should be part of the routine management of kidney transplant recipients. Pro. Am J Kidney Dis. 2002 Oct;40(4):671-3. doi: 10.1053/ajkd.2002.36427. No abstract available.
- Background: PubMed 27306873Rose EM, Kennedy SE, Mackie FE. Surveillance biopsies after paediatric kidney transplantation: A review. Pediatr Transplant. 2016 Sep;20(6):748-55. doi: 10.1111/petr.12733. Epub 2016 Jun 16.
- Background: PubMed 15009838Birk PE, Stannard KM, Konrad HB, Blydt-Hansen TD, Ogborn MR, Cheang MS, Gartner JG, Gibson IW. Surveillance biopsies are superior to functional studies for the diagnosis of acute and chronic renal allograft pathology in children. Pediatr Transplant. 2004 Feb;8(1):29-38. doi: 10.1046/j.1397-3142.2003.00122.x.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant Rejection
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingPhase 1
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
Kidney Transplant Rejection
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Recruiting
Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced NK-mediated Rejection
Kidney Transplant Failure and Rejection
Enrolling by invitationObservational study
GEnomic Medicine in Kidney Transplantation Study
Transplant Complication, Kidney Transplant Rejection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patty West-Thielke, PharmD study director
Transplant Genomics
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection, run by Transplant Genomics, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cortney Miller, PhD (5107753326, cortneymiller@eurofins-tgi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of Biomarkers with protocol biopsy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335538, which also lists 62 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.