Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640283
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Dynamic ctDNA Assessment in Cervical and Anal Canal Tumors Optimizing Follow-up and Clinical Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dynamic Assessment of ctDNA in Patients With Cervical and Anal Canal Tumors to Optimize Follow-up and Clinical Outcomes in the Brazilian Unified Health System SUS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANA
Brief Summary:
After definitive radiotherapy RT treatment with or without chemotherapy cervical and anal canal neoplasms frequently exhibit disease persistence or recurrence Due to the local inflammatory process post-treatment response assessment by imaging current gold standard is limited often necessitating multiple follow-ups and repeated invasive biopsies Conventional follow-up is complex and costly requiring equipment from secondary and tertiary services trained radiologists and patient exposure to radiation and contrast
In this context of human papillomavirusHPV-related neoplasms recent studies have demonstrated the role of ctDNA circulating tumor DNA in assessing the risk of recurrence or disease progression providing a rationale for using the tool in two fronts
Optimizing follow-up based on serial monitoring of ctDNA
Selecting patients with positive ctDNA after RT who are at high risk of recurrence for treatment intensification
Monitoring with ctDNA as a standalone follow-up tool in cases evolving with negative ctDNA after RT has the potential to replace imaging exams being a minimally invasive test performed on a peripheral blood sample Currently ctDNA testing has expensive methodologies not available in the Unified Health System SUS This project aims to develop a methodology for ctDNA evaluation focused on HPV ctDNA research that is low-cost and executable in SUS as well to assess the accuracy of this test in the population with HPV-related tumors
Additionally we will evaluate whether the early introduction of immunotherapy in patients with positive ctDNA after definitive treatment can increase cure rates Immunotherapy already has a well-defined role in the treatment of metastatic HPV-related neoplasms Recently the use of anti-programmed death-1 anti-PD1 has also shown benefits in patients with locally advanced cervical cancer with a high risk of recurrence who are candidates for chemoradiotherapy CRT Therefore its use focused on HPV-related tumors as well as a better understanding of which patients benefit from this strategy warrants further investigation
In this context of human papillomavirusHPV-related neoplasms recent studies have demonstrated the role of ctDNA circulating tumor DNA in assessing the risk of recurrence or disease progression providing a rationale for using the tool in two fronts
Optimizing follow-up based on serial monitoring of ctDNA
Selecting patients with positive ctDNA after RT who are at high risk of recurrence for treatment intensification
Monitoring with ctDNA as a standalone follow-up tool in cases evolving with negative ctDNA after RT has the potential to replace imaging exams being a minimally invasive test performed on a peripheral blood sample Currently ctDNA testing has expensive methodologies not available in the Unified Health System SUS This project aims to develop a methodology for ctDNA evaluation focused on HPV ctDNA research that is low-cost and executable in SUS as well to assess the accuracy of this test in the population with HPV-related tumors
Additionally we will evaluate whether the early introduction of immunotherapy in patients with positive ctDNA after definitive treatment can increase cure rates Immunotherapy already has a well-defined role in the treatment of metastatic HPV-related neoplasms Recently the use of anti-programmed death-1 anti-PD1 has also shown benefits in patients with locally advanced cervical cancer with a high risk of recurrence who are candidates for chemoradiotherapy CRT Therefore its use focused on HPV-related tumors as well as a better understanding of which patients benefit from this strategy warrants further investigation
Detailed Description:
The ANA study is a research project aimed at enhancing the treatment and outcomes for patients with cervical and anal canal cancer by using innovative diagnostic and therapeutic methods The study consists of the following phases
Patient identification and selection
Recruitment of patients diagnosed with cervical or anal canal cancer who are candidates for treatment with radiotherapy RT with or without chemotherapy patients will be selected based on specific criteria to ensure a representative cohort
Development and validation of the ctDNA HPV Test development of a sensitive and specific test to detect HPV DNA in the blood This test will undergo rigorous validation to ensure its accuracy and reliability
ctDNA monitoring blood samples collection from patients during treatment and follow-up ctDNA levels will be monitored in real-time to early detection of residual or recurrent disease This non-invasive method aims to provide a more accurate assessment of treatment efficacy and disease progression The results of ctDNA will be compared with traditional imaging methods
Complementary immunotherapy treatment patients with positive ctDNA results after chemoradiotherapy will be considered for additional immunotherapy This phase will evaluate the benefits of combining immunotherapy with standard chemoradiotherapy in order to improve patient outcomes
Follow-up and outcome evaluation long-term follow-up of patients to assess clinical outcomes including survival and quality of life
The ANA study aims to set new standards in the follow-up and management of HPV-related cervical and anal canal cancer by improving patient care within the Brazilian public health system SUS
Patient identification and selection
Recruitment of patients diagnosed with cervical or anal canal cancer who are candidates for treatment with radiotherapy RT with or without chemotherapy patients will be selected based on specific criteria to ensure a representative cohort
Development and validation of the ctDNA HPV Test development of a sensitive and specific test to detect HPV DNA in the blood This test will undergo rigorous validation to ensure its accuracy and reliability
ctDNA monitoring blood samples collection from patients during treatment and follow-up ctDNA levels will be monitored in real-time to early detection of residual or recurrent disease This non-invasive method aims to provide a more accurate assessment of treatment efficacy and disease progression The results of ctDNA will be compared with traditional imaging methods
Complementary immunotherapy treatment patients with positive ctDNA results after chemoradiotherapy will be considered for additional immunotherapy This phase will evaluate the benefits of combining immunotherapy with standard chemoradiotherapy in order to improve patient outcomes
Follow-up and outcome evaluation long-term follow-up of patients to assess clinical outcomes including survival and quality of life
The ANA study aims to set new standards in the follow-up and management of HPV-related cervical and anal canal cancer by improving patient care within the Brazilian public health system SUS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None