Breast NeoplasmGIRO_ctDNANCT05050890
Prognostic Value of Circulating Tumor DNA Dosing in Patients in Neoadjuvant Breast Neoplasia
An observational study of Breast Neoplasm, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
Trial summary
This is a cohort, single-center, prospective study that seeks to analyze the circulating tumor DNA (ctDNA) in patients diagnosed with breast cancer, who will undergo neoadjuvant treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- ctDNA level during neoadjuvant chemotherapy
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2020to 28 Feb 2022
- How long will I take part?
- 1 Year
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with breast cancer who are considered possible candidates for neoadjuvant chemotherapy
Who may be able to join
- Information to the patient and signed informed consent;
- Locally advanced breast cancer that is a candidate for neoadjuvant therapy;
- Histological diagnosis of localized invasive breast carcinoma, confirmed by the pathologist, with or without expression of hormone receptors, and/or with the presence of HER-2.
Who cannot join
- Metastatic breast cancer (Stage IV);
- Additional invasive malignant disease;
- Known psychiatric or substance abuse disorders that may interfere with cooperation with study requirements;
- Presents any organic condition that makes it impossible to carry out chemotherapy treatment;
- Pregnant or lactating women
- Received previous treatment for breast cancer.
Trial locations and contacts
1 site in 1 country.
About this study
This is a cohort, single-center, prospective study that seeks to analyze the circulating tumor DNA (ctDNA) in patients diagnosed with breast cancer, who will undergo neoadjuvant treatment.
Read the detailed description
Breast cancer is a major public health problem, being the most common cancer in women worldwide. Breast cancer can be diagnosed through multiple tests, including an imaging and tissue biopsy. However, accurate assessment and prediction of the response is a major challenge. Circulating tumor DNA (ctDNA) has shown promise in the detection of breast cancer and clinical and cancer outcomes.
This study aims to evaluate a possible correlations between ctDNA levels with the pathological complete response and detection of residual disease after neoadjuvant therapy in patients with breast cancer.
In order to start ctDNA surveillance, patients will be asked to participate in blood draws, every 15 days, during neoadjuvant standard institutional treatment and allow study staff to review medical records.
- Conditions
- Breast Neoplasm
- Being tested
- ctDNA level during neoadjuvant chemotherapy
- Keywords
- Breast Cancer, Liquid Biopsy, ctDNA, Pathologic complete response
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA level during neoadjuvant chemotherapyOther
ctDNA samples will be collected from patients at baseline, during neoadjuvant therapy (every 15 days) and before the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Breast cancer patients who are currently receiving neoadjuvant therapy Receives: Other: ctDNA level during neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of circulating DNA(ctDNA)
Circulating tumor DNA (ctDNA) levels will be measured each 15 days until end of neoadjuvant therapy, through peripheral blood collection
Measured: From date of enrollment until the date of end of neoadjuvant treatment, assessed up to 6-7 months
Secondary outcomes (1)
Change from baseline ctDNA alterations to end of neoadjuvant treatment
The percentage of patients with ctDNA alterations will be provided over time of neoadjuvant treatment to characterize the biological evolution of the disease in each patient. The association of these alterations with clinical outcomes will also be provided.
Measured: Up to approximately 7 months starting from Baseline until end of neoadjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start5 Aug 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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
- 38 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Instituto Brasileiro de Controle do Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camila Giro, Instituto Brasileiro de Controle do Cancer
- Investigators
- Camila Giro, MD, Principal investigator, IBCC Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050890
- Sponsor's protocol ID
- 32158620.0.0000.0072
- Acronym
- GIRO_ctDNA
- Status last verified
- Aug 2021
- First submitted
- 10 Sep 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The findings will be shared and discussed with all investigators in the study. A study manuscript, having received contributions from all authors, will be submitted for publication in scientific circles.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Circulating Tumor DNA Dosing in Patients in Neoadjuvant Breast Neoplasia
- ClinicalTrials.gov ID
- NCT05050890
- Acronym / sponsor ID
- GIRO_ctDNA / 32158620.0.0000.0072
- Conditions
- Breast Neoplasm
- Keywords
- Breast Cancer, Liquid Biopsy, ctDNA, Pathologic complete response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Instituto Brasileiro de Controle do CancerUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 21 Sep 2021 (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 cohort, single-center, prospective study that seeks to analyze the circulating tumor DNA (ctDNA) in patients diagnosed with breast cancer, who will undergo neoadjuvant treatment.
Detailed description
Breast cancer is a major public health problem, being the most common cancer in women worldwide. Breast cancer can be diagnosed through multiple tests, including an imaging and tissue biopsy. However, accurate assessment and prediction of the response is a major challenge. Circulating tumor DNA (ctDNA) has shown promise in the detection of breast cancer and clinical and cancer outcomes.
This study aims to evaluate a possible correlations between ctDNA levels with the pathological complete response and detection of residual disease after neoadjuvant therapy in patients with breast cancer.
In order to start ctDNA surveillance, patients will be asked to participate in blood draws, every 15 days, during neoadjuvant standard institutional treatment and allow study staff to review medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | Other: ctDNA level during neoadjuvant chemotherapyBreast cancer patients who are currently receiving neoadjuvant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with breast cancer who are considered possible candidates for neoadjuvant chemotherapy
Key inclusion criteria (3 listed)
- Information to the patient and signed informed consent;
- Locally advanced breast cancer that is a candidate for neoadjuvant therapy;
- Histological diagnosis of localized invasive breast carcinoma, confirmed by the pathologist, with or without expression of hormone receptors, and/or with the presence of HER-2.
Key exclusion criteria (6 listed)
- Metastatic breast cancer (Stage IV);
- Additional invasive malignant disease;
- Known psychiatric or substance abuse disorders that may interfere with cooperation with study requirements;
- Presents any organic condition that makes it impossible to carry out chemotherapy treatment;
- Pregnant or lactating women
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 |
|---|---|---|
| ctDNA level during neoadjuvant chemotherapyctDNA samples will be collected from patients at baseline, during neoadjuvant therapy (every 15 days) and before the surgical procedure | Other | Breast cancer |
Primary outcome
The concentration of circulating DNA(ctDNA)
Time frame: From date of enrollment until the date of end of neoadjuvant treatment, assessed up to 6-7 months
Circulating tumor DNA (ctDNA) levels will be measured each 15 days until end of neoadjuvant therapy, through peripheral blood collection
1 secondary outcome
Change from baseline ctDNA alterations to end of neoadjuvant treatment
Time frame: Up to approximately 7 months starting from Baseline until end of neoadjuvant treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No. The findings will be shared and discussed with all investigators in the study. A study manuscript, having received contributions from all authors, will be submitted for publication in scientific circles.
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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.
Camila Giro, MD principal investigator
IBCC Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
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 3 inclusion and 6 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 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
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?
The concentration of circulating DNA(ctDNA) (time frame: From date of enrollment until the date of end of neoadjuvant treatment, assessed up to 6-7 months). 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 30 Sep 2021.