Patients With Locally Advanced Rectal CancerREVEALNCT05674422
GEMCAD-REVEAL STUDY - Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer.
An observational study of Patients With Locally Advanced Rectal Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 15 sites in Spain.
Trial summary
The evaluation of the tumor response to chemoradiotherapy/total neoadjuvant therapy (CRT/TNT) remains a challenge. The integration of a blood-based biomarker such as ctDNA with clinico-radiological tools could offer the potential advantage of improving accuracy of assessment of tumor response to neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Locally Advanced Rectal Cancer
- What is being tested?
- total neoadjuvant therapy
- How many people
- 120 participants
- Where
- 15 sitesSpain
- Study dates
- 26 May 2023to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with locally advanced rectal cancer candidates to TNT. All patients will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All enrolled patients will be allocated to receive TNT according to standard clinical practice.
Who may be able to join
- Legally capable patients ≥ 18 years of age.
- Histologically confirmed rectal adenocarcinoma.
- Any tumor located in the mid or distal rectum, clinically staged II-III (cT3/4 and/or any TN+).
- Willingness to be enrolled in the WW strategy if cCR or nCCR is achieved.
- Absence of metastases on imaging.
- Scheduled to undergo TNT followed by delayed surgery.
- Patients who have signed the informed consent for this study.
- Note: Decision was taken to treat the patient with a specific treatment prior and independently of patient inclusion in this non interventional study.
Who cannot join
- Patients who do not meet inclusion criteria.
- Concomitant colorectal tumors.
- Intolerance or contraindication to planned TNT.
- Other concurrent malignant diseases. Pregnancy or breastfeeding.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital Germans Trias i Pujol - ICO Badalona
Badalona, Barcelona
H. de la Santa Creu i Sant Pau
Barcelona
H.U. Vall d'Hebron
Barcelona
Hospital Clínic, Universitat de Barcelona
Barcelona
Hospital Del Mar, Barcelona
Barcelona
Hospital Sant Joan Despí - Moisés Broggi.
Barcelona
ICO-Hospitalet
Barcelona
ICO Girona
Girona
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
H. Univeristario La Paz
Madrid
Hospital Universitari Mutua de Terrassa
Terrassa, Barcelona
Hospital Quirón Salud Valencia
Valencia
Hospital Universitari i Politècnic La Fe
Valencia
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Hospital Universitario Miguel Servet
Zaragoza
About this study
Official title: Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer Treated With Total Neoadjuvant Therapy Followed by Watch and Wait or Total Mesorectal Excision Based on Clinical Assessment of Response
The evaluation of the tumor response to chemoradiotherapy/total neoadjuvant therapy (CRT/TNT) remains a challenge. The integration of a blood-based biomarker such as ctDNA with clinico-radiological tools could offer the potential advantage of improving accuracy of assessment of tumor response to neoadjuvant therapy. Furthermore, data on functional outcomes and quality of life after total mesorectal excision (TME) and especially after " Watch And Wait" (WW) is scarce.
REVEAL is a prospective, multicenter study in which the response to TNT in correlation with liquid biopsy (LB) of patients with rectal cancer in Spain will be evaluated. It is planned to include 120 patients. All patients will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All cases and treatment decisions will be discussed by local Multidisciplinary Boards. Patients will be included consecutively when visiting the corresponding health centers for outpatient visits or hospitalization.
The objective of the present study is to evaluate the role of ctDNA in the prediction of relapse in patients diagnosed with locally advanced rectal cancer (LARC) treated with TNT followed by WW or TME based on a clinical assessment of the local response
Read the detailed description
The evaluation of the tumor response to chemoradiotherapy/total neoadjuvant therapy (CRT/TNT) remains a challenge. The integration of a blood-based biomarker such as ctDNA with clinico-radiological tools could offer the potential advantage of improving accuracy of assessment of tumor response to neoadjuvant therapy. Furthermore, data on functional outcomes and quality of life after total mesorectal excision (TME) and especially after " Watch And Wait" (WW) is scarce.
REVEAL is a prospective, multicenter study in which the response to TNT in correlation with liquid biopsy (LB) of patients with rectal cancer in Spain will be evaluated. It is planned to include 120 patients. All patients will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All cases and treatment decisions will be discussed by local Multidisciplinary Boards. Patients will be included consecutively when visiting the corresponding health centers for outpatient visits or hospitalization.
The objective of the present study is to evaluate the role of ctDNA in the prediction of relapse in patients diagnosed with locally advanced rectal cancer (LARC) treated with TNT followed by WW or TME based on a clinical assessment of the local response.
HYPOTHESIS ctDNA is a predictor of complete clinical response and could potentially be used to guide patient selection for WW strategy.
ctDNA is an early marker of local tumor relapse and could potentially guide strategy changes during follow-up.
Patients who are enrolled in a WW strategy have better long-term functional outcomes in comparison to patients who undergo surgery.
OBJECTIVES
PRIMARY:
To estimate the positive predictive value (PPV) and the negative predictive value (NPV) of the post-TNT ctDNA measurement to identify relapse (local or distant) in the 2 years after TNT.
SECONDARY:
Secondary objectives related to ctDNA and tumor response to TNT:
- To estimate the concordance between the post-TNT ctDNA measurement and the clinical evaluation of response (endoscopy-biopsy, DRE and MRI) to TNT.
- To estimate the concordance between the ctDNA measured after TNT and the endoscopy-biopsy evaluation of response.
- To estimate the concordance between the ctDNA measured after TNT and the MRI-defined response pattern groups.
Secondary objectives related to ctDNA measure during follow-up and relapse:
- To estimate the positive predictive value and the negative predictive value of ctDNA measured during the follow-up after TNT to identify relapse (local or distant) in the 2 years after TNT.
- To estimate the positive predictive value and the negative predictive value of ctDNA measured during the follow-up after TNT to identify local relapse in the 2 years after TNT
- To estimate the positive predictive value and the negative predictive value of ctDNA measured during the follow-up after TNT to identify distant relapse in the 2 years after TNT
Secondary objective related to functional impact of TME and WW:
-To describe anorectal, urinary and sexual function in the TME and WW groups.
Secondary objective related to ctDNA and survival:
-To assess the association of ctDNA levels (at baseline, post-treatment and during follow-up) with the survival outcomes (overall and disease-free survival, locoregional and distant recurrence, together with the pattern of recurrence).
- Being tested
- total neoadjuvant therapy
- Keywords
- rectal cancer, ctDNA, total neoadjuvant therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total neoadjuvant therapyDrug
All patients will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All cases and treatment decisions will be discussed by local Multidisciplinary Boards
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA from liquid biopsy
The results from ctDNA will be dichotomized to positive or negative. The investigator will report the percentage of patients with positive or negative ctDNA. Correlation of these values with clinical endpoints of response / survival to total neoadjuvant therapy will be done to fulfill the proposed objectives of this study. The ctDNA isolation test selected for this study is marketed by Guardant Health (Redwood City, California, USA) under the name Guardant RevealTM. It consists of a single state-of-the-art liquid blood biopsy, which is capable of detecting residual or recurrent disease seven days after blood extraction. This test uses a sequencing method that simultaneously evaluates genetic alterations and methylation without the need for a biopsy of the primary tumor tissue to determine specific mutations.
Measured: 2 years after to start treatment total neoadjuvant therapy/2 years per patient
Secondary outcomes (9)
Response to TNT (cCR,nCCR)
Number of patients will be classified as responders (cCR, nCCR) or non responders based on the International Consensus Recommendations for Organ Preservation in Rectal Cancer. The number and percentage of each category will be reported.
cCR: clinical complete response nCCR: near-complete clinical response
Measured: Throughout the study period, approximately 2 years per patient
Response to TNT (WW or TME)
The number and percentage of patients allocated to "watch and wait" (WW) or Total Mesorectal Excision (TMT) will be provided. Response rates will be also provided separately depending on the technique empowered to determine the response:
- Endoscopy-biopsy
- MRI
Measured: Throughout the study period, approximately 2 years per patient
Locoregional failure rate (LRF)
Locoregional failure rate (LRF) defined as the percentage of patients who present progression(only for patients with nCCR)/relapse of disease in the rectum, regional organs and/or regional lymph nodes. Locoregional failure rate will be estimated using the appropriate logistic regression model at 1-year after the first dose of TNT and end of study. Those patients lost to follow-up with no event of local recurrence will be considered not evaluable for LFR endpoint. Patients who die as a direct or secondary cause of the cancer will be considered as an event at the date of death for LFR analysis. Death by other reasons other than cancer progression/relapse will not be considered as an event for LFR.
Measured: Throughout the study period, approximately 2 years per patient
Distant relapse rate (DRR)
Distant relapse rate (DRR) defined as the percentage of patients who present progression/relapse of disease in distant locations. DRR will be estimated using the appropriate logistic regression model at 1-year after the first dose of TNT and end of study. Those patients lost to follow-up with no event of distal recurrence will be considered not evaluable for DRR endpoint. Patients who die as a direct or secondary cause of the cancer will be considered as an event at the date of death for DRR analysis. Death by other reasons other than cancer progression/relapse will not be considered as an event for DRR.
Measured: Throughout the study period, approximately 2 years per patient
Disease-free Survival (DFS)
Disease-free Survival (DFS): defined as the time elapsed from the first dose of TNT to progression (only for pts with nCCR), relapse, or death from any cause, whichever occurs first. The investigators will assess the median DFS, the DFS rate at 1 year, and at the end of study. The 1-year DFS rate is defined as the rate of patients alive and free of relapse or progression at 1 year after the first dose of TNT estimated by Kaplan-Meier. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment.
Measured: at 1 year after the first dose of TNT and at the end of study (approximately 2 years)
Disease-specific Survival (DSS)
Disease-specific Survival (DSS): defined as the time elapsed from the first dose of TNT to the date of progression(only for pts with nCCR), relapse, or death due to the disease, whichever occurs first. We will assess the median DSS, the DSS rate at 1 year, and at the end of study. The 1-year DSS rate is defined as the rate of patients alive and free of event at 1 year after the first dose of TNT, estimated by Kaplan-Meier. Patients alive and free of events at the date of the analysis will be censored at their last known contact.
Measured: at 1 year after the first dose of TNT
Overall Survival (OS)
Overall Survival (OS) : defined as the time elapsed from the first dose of TNT until death from any cause. We will assess the median OS and the OS rate at 1 year. The 1-year OS rate is defined as the rate of patients alive at 1 year after the first dose of TNT, estimated by Kaplan-Meier. Patients alive and free of events at the date of the analysis will be censored at their last known contact.
Measured: at 1 year after the first dose of TNT
Mortality
Mortality: Rate of patients who died during the study. The number and percentage of patients will be provided.
Measured: Throughout the study period, approximately 2 years per patient
TNT compliance
TNT compliance: total number of dose reductions and modifications of the treatment throughout the study period.
Measured: Throughout the study period, approximately 2 years per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start26 May 2023
- Primary completion26 Apr 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Locally Advanced Rectal CancerStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoelimar Guzmán, M.D., Study chair, Servicio de Cirugía General y Digestiva, Hospital Clínic, Universitat de BarcelonaJoan Maurel Santasusana, M.D., Ph.D., Study chair, Servicio de Oncología, Hospital Clínic, Universitat de BarcelonaJuan Ramón Ayuso, M.D., Ph.D., Study chair, Servicio de Radiología, Hospital Clínic, Universitat de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674422
- Sponsor's protocol ID
- GEMCAD 2201
- Acronym
- REVEAL
- Status last verified
- Oct 2024
- First submitted
- 30 Dec 2022
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer Treated With Total Neoadjuvant Therapy Followed by Watch and Wait or Total Mesorectal Excision Based on Clinical Assessment of Response
- ClinicalTrials.gov ID
- NCT05674422
- Acronym / sponsor ID
- REVEAL / GEMCAD 2201
- Keywords
- rectal cancer, ctDNA, total neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer DigestivoUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 26 Apr 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Jan 2023 (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.
The evaluation of the tumor response to chemoradiotherapy/total neoadjuvant therapy (CRT/TNT) remains a challenge. The integration of a blood-based biomarker such as ctDNA with clinico-radiological tools could offer the potential advantage of improving accuracy of assessment of tumor response to neoadjuvant therapy. Furthermore, data on functional outcomes and quality of life after total mesorectal excision (TME) and especially after " Watch And Wait" (WW) is scarce.
REVEAL is a prospective, multicenter study in which the response to TNT in correlation with liquid biopsy (LB) of patients with rectal cancer in Spain will be evaluated. It is planned to include 120 patients. All patients will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All cases and treatment decisions will be discussed by local Multidisciplinary Boards. Patients will be included consecutively when visiting the corresponding health centers for outpatient visits or hospitalization.
The objective of the present study is to evaluate the role of ctDNA in the prediction of relapse in patients diagnosed with locally advanced rectal cancer (LARC) treated with TNT followed by WW or TME based on a clinical assessment of the local response
Detailed description
The evaluation of the tumor response to chemoradiotherapy/total neoadjuvant therapy (CRT/TNT) remains a challenge. The integration of a blood-based biomarker such as ctDNA with clinico-radiological tools could offer the potential advantage of improving accuracy of assessment of tumor response to neoadjuvant therapy. Furthermore, data on functional outcomes and quality of life after total mesorectal excision (TME) and especially after " Watch And Wait" (WW) is scarce.
REVEAL is a prospective, multicenter study in which the response to TNT in correlation with liquid biopsy (LB) of patients with rectal cancer in Spain will be evaluated. It is planned to include 120 patients. All patients will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All cases and treatment decisions will be discussed by local Multidisciplinary Boards. Patients will be included consecutively when visiting the corresponding health centers for outpatient visits or hospitalization.
The objective of the present study is to evaluate the role of ctDNA in the prediction of relapse in patients diagnosed with locally advanced rectal cancer (LARC) treated with TNT followed by WW or TME based on a clinical assessment of the local response.
HYPOTHESIS ctDNA is a predictor of complete clinical response and could potentially be used to guide patient selection for WW strategy.
ctDNA is an early marker of local tumor relapse and could potentially guide strategy changes during follow-up.
Patients who are enrolled in a WW strategy have better long-term functional outcomes in comparison to patients who undergo surgery.
OBJECTIVES
PRIMARY:
To estimate the positive predictive value (PPV) and the negative predictive value (NPV) of the post-TNT ctDNA measurement to identify relapse (local or distant) in the 2 years after TNT.
SECONDARY:
Secondary objectives related to ctDNA and tumor response to TNT:
- To estimate the concordance between the post-TNT ctDNA measurement and the clinical evaluation of response (endoscopy-biopsy, DRE and MRI) to TNT.
- To estimate the concordance between the ctDNA measured after TNT and the endoscopy-biopsy evaluation of response.
- To estimate the concordance between the ctDNA measured after TNT and the MRI-defined response pattern groups.
Secondary objectives related to ctDNA measure during follow-up and relapse:
- To estimate the positive predictive value and the negative predictive value of ctDNA measured during the follow-up after TNT to identify relapse (local or distant) in the 2 years after TNT.
- To estimate the positive predictive value and the negative predictive value of ctDNA measured during the follow-up after TNT to identify local relapse in the 2 years after TNT
- To estimate the positive predictive value and the negative predictive value of ctDNA measured during the follow-up after TNT to identify distant relapse in the 2 years after TNT
Secondary objective related to functional impact of TME and WW:
-To describe anorectal, urinary and sexual function in the TME and WW groups.
Secondary objective related to ctDNA and survival:
-To assess the association of ctDNA levels (at baseline, post-treatment and during follow-up) with the survival outcomes (overall and disease-free survival, locoregional and distant recurrence, together with the pattern of recurrence).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with locally advanced rectal cancer candidates to TNT. All patients will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All enrolled patients will be allocated to receive TNT according to standard clinical practice.
Key inclusion criteria (8 listed)
- Legally capable patients ≥ 18 years of age.
- Histologically confirmed rectal adenocarcinoma.
- Any tumor located in the mid or distal rectum, clinically staged II-III (cT3/4 and/or any TN+).
- Willingness to be enrolled in the WW strategy if cCR or nCCR is achieved.
- Absence of metastases on imaging.
Key exclusion criteria (4 listed)
- Patients who do not meet inclusion criteria.
- Concomitant colorectal tumors.
- Intolerance or contraindication to planned TNT.
- Other concurrent malignant diseases. Pregnancy or breastfeeding.
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 |
|---|---|---|
| total neoadjuvant therapyAll patients will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All cases and treatment decisions will be discussed by local Multidisciplinary Boards | Drug | – |
Primary outcome
ctDNA from liquid biopsy
Time frame: 2 years after to start treatment total neoadjuvant therapy/2 years per patient
The results from ctDNA will be dichotomized to positive or negative. The investigator will report the percentage of patients with positive or negative ctDNA. Correlation of these values with clinical endpoints of response / survival to total neoadjuvant therapy will be done to fulfill the proposed objectives of this study. The ctDNA isolation test selected for this study is marketed by Guardant Health (Redwood City, California, USA) under the name Guardant RevealTM. It consists of a single state-of-the-art liquid blood biopsy, which is capable of detecting residual or recurrent disease seven days after blood extraction. This test uses a sequencing method that simultaneously evaluates genetic alterations and methylation without the need for a biopsy of the primary tumor tissue to determine specific mutations.
9 secondary outcomes
Response to TNT (cCR,nCCR)
Time frame: Throughout the study period, approximately 2 years per patient
Response to TNT (WW or TME)
Time frame: Throughout the study period, approximately 2 years per patient
Locoregional failure rate (LRF)
Time frame: Throughout the study period, approximately 2 years per patient
Distant relapse rate (DRR)
Time frame: Throughout the study period, approximately 2 years per patient
Disease-free Survival (DFS)
Time frame: at 1 year after the first dose of TNT and at the end of study (approximately 2 years)
Disease-specific Survival (DSS)
Time frame: at 1 year after the first dose of TNT
Overall Survival (OS)
Time frame: at 1 year after the first dose of TNT
Mortality
Time frame: Throughout the study period, approximately 2 years per patient
TNT compliance
Time frame: Throughout the study period, approximately 2 years per patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Yoelimar Guzmán, M.D. study chair
Servicio de Cirugía General y Digestiva, Hospital Clínic, Universitat de Barcelona
Joan Maurel Santasusana, M.D., Ph.D. study chair
Servicio de Oncología, Hospital Clínic, Universitat de Barcelona
Juan Ramón Ayuso, M.D., Ph.D. study chair
Servicio de Radiología, Hospital Clínic, Universitat de Barcelona
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Locally Advanced Rectal Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 15 sites in Spain.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA from liquid biopsy (time frame: 2 years after to start treatment total neoadjuvant therapy/2 years per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2024.