Brest CancerNCT06820554
Thyroid Dysfunction Induced by Radiotherapy Treatment in Patients with Breast Cancer
An observational study of Brest Cancer, run by Assiut University.
Trial summary
Breast cancer is the most common cancer and second most common cause of cancer death among US women,. External beam radiation therapy (RT) that involves the breast and regional lymph nodes, including axillary and supraclavicular (SCV) lymph nodes, has been demonstrated to decrease the risk of local recurrence and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brest Cancer
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 May 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: breast cancer patients who will be indicated for postoperative ( mastectomy /BCT) adjuvant radiotherapy
Who may be able to join
- >18 yrs old breast cancer ( pathological proved )
- Stage II/III breast cancer
- High risk local recurrence ( LVI/ G3/ LN positive)
- Non metastatic breast cancer
Who cannot join
- Thyriod dysfunction of any othe cause( no known pretreatment primary thyroid disease or dysfunction; no prior thyroid surgery; and no prior RT that involved the hypothalamic-pituitary axis or thyroid
About this study
Breast cancer is the most common cancer and second most common cause of cancer death among US women,. External beam radiation therapy (RT) that involves the breast and regional lymph nodes, including axillary and supraclavicular (SCV) lymph nodes, has been demonstrated to decrease the risk of local recurrence and improve long-term survival in high-risk breast cancer patients .
However, RT-induced toxicities to adjacent normal tissues can lead to serious morbidity in cancer survivors .
Read more
The thyroid regulates the body's metabolism via producing thyroxine (T4) and triiodothyronine (T3) hormones. As the thyroid is sensitive to RT, radiation-induced thyroid disorders have been reported in cancer patients who received radiation in the cervical or SCV regions .
In breast cancer patients, RT to the SCV area has been associated with a higher incidence of Hypothyriodism, particularly in younger patients This complication may be associated with radiation-induced thyroid volume reduction .
Recent studies,have reported a significant decrease in thyroid volume (14-30 %) in patients with laryngeal or nasopharyngeal carcinoma (NPC), suggesting an association between HT and post-RT thyroid atrophy .
Little is known about the changes of thyroid gland volume based on local thyroid gland radiation dose and its correlations with incidence of HT.
Our study aim the changes in thyroid volume of breast cancer patients who received RT to the SCV nodal area, to evaluate RT-induced thyroid gland evolution based on local radiation dose. We then assessed the association between thyroid volume changes and the incidence of post-RT Hypothyrodism in breast cancer patients.
the aim of the study to diagnose subclinical hypothyroidism and biochemical changes in thyroid function after radiotherapy for breast cancer
Read the detailed description
Breast cancer is the most common cancer and second most common cause of cancer death among US women,. External beam radiation therapy (RT) that involves the breast and regional lymph nodes, including axillary and supraclavicular (SCV) lymph nodes, has been demonstrated to decrease the risk of local recurrence and improve long-term survival in high-risk breast cancer patients .
However, RT-induced toxicities to adjacent normal tissues can lead to serious morbidity in cancer survivors .
The thyroid regulates the body's metabolism via producing thyroxine (T4) and triiodothyronine (T3) hormones. As the thyroid is sensitive to RT, radiation-induced thyroid disorders have been reported in cancer patients who received radiation in the cervical or SCV regions .
In breast cancer patients, RT to the SCV area has been associated with a higher incidence of Hypothyriodism, particularly in younger patients This complication may be associated with radiation-induced thyroid volume reduction .
Recent studies,have reported a significant decrease in thyroid volume (14-30 %) in patients with laryngeal or nasopharyngeal carcinoma (NPC), suggesting an association between HT and post-RT thyroid atrophy .
Little is known about the changes of thyroid gland volume based on local thyroid gland radiation dose and its correlations with incidence of HT.
Our study aim the changes in thyroid volume of breast cancer patients who received RT to the SCV nodal area, to evaluate RT-induced thyroid gland evolution based on local radiation dose. We then assessed the association between thyroid volume changes and the incidence of post-RT Hypothyrodism in breast cancer patients.
the aim of the study to diagnose subclinical hypothyroidism and biochemical changes in thyroid function after radiotherapy for breast cancer
- Conditions
- Brest Cancer
- Keywords
- Thyroid dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| brest cancer | breast cancer patients who will be indicated for postoperative ( mastectomy /BCT) adjuvant radiotherapy who are>18 yrs old breast cancer ( pathological proved ) Stage II/III breast cancer High risk local recurrence ( LVI/ G3/ LN positive) Non metastatic breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of subclinical hypothyroidism
subclinical hypothyroidism after radiotherapy for breast cancer
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brest CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatmaelzahraa mohamed said, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820554
- Sponsor's protocol ID
- TD radio brest cancer
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Dysfunction Induced by Radiotherapy Treatment in Patients with Breast Cancer
- ClinicalTrials.gov ID
- NCT06820554
- Acronym / sponsor ID
- TD radio brest cancer
- Conditions
- Brest Cancer
- Keywords
- Thyroid dysfunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 11 Feb 2025 (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.
Breast cancer is the most common cancer and second most common cause of cancer death among US women,. External beam radiation therapy (RT) that involves the breast and regional lymph nodes, including axillary and supraclavicular (SCV) lymph nodes, has been demonstrated to decrease the risk of local recurrence and improve long-term survival in high-risk breast cancer patients .
However, RT-induced toxicities to adjacent normal tissues can lead to serious morbidity in cancer survivors .
The thyroid regulates the body's metabolism via producing thyroxine (T4) and triiodothyronine (T3) hormones. As the thyroid is sensitive to RT, radiation-induced thyroid disorders have been reported in cancer patients who received radiation in the cervical or SCV regions .
In breast cancer patients, RT to the SCV area has been associated with a higher incidence of Hypothyriodism, particularly in younger patients This complication may be associated with radiation-induced thyroid volume reduction .
Recent studies,have reported a significant decrease in thyroid volume (14-30 %) in patients with laryngeal or nasopharyngeal carcinoma (NPC), suggesting an association between HT and post-RT thyroid atrophy .
Little is known about the changes of thyroid gland volume based on local thyroid gland radiation dose and its correlations with incidence of HT.
Our study aim the changes in thyroid volume of breast cancer patients who received RT to the SCV nodal area, to evaluate RT-induced thyroid gland evolution based on local radiation dose. We then assessed the association between thyroid volume changes and the incidence of post-RT Hypothyrodism in breast cancer patients.
the aim of the study to diagnose subclinical hypothyroidism and biochemical changes in thyroid function after radiotherapy for breast cancer
Detailed description
Breast cancer is the most common cancer and second most common cause of cancer death among US women,. External beam radiation therapy (RT) that involves the breast and regional lymph nodes, including axillary and supraclavicular (SCV) lymph nodes, has been demonstrated to decrease the risk of local recurrence and improve long-term survival in high-risk breast cancer patients .
However, RT-induced toxicities to adjacent normal tissues can lead to serious morbidity in cancer survivors .
The thyroid regulates the body's metabolism via producing thyroxine (T4) and triiodothyronine (T3) hormones. As the thyroid is sensitive to RT, radiation-induced thyroid disorders have been reported in cancer patients who received radiation in the cervical or SCV regions .
In breast cancer patients, RT to the SCV area has been associated with a higher incidence of Hypothyriodism, particularly in younger patients This complication may be associated with radiation-induced thyroid volume reduction .
Recent studies,have reported a significant decrease in thyroid volume (14-30 %) in patients with laryngeal or nasopharyngeal carcinoma (NPC), suggesting an association between HT and post-RT thyroid atrophy .
Little is known about the changes of thyroid gland volume based on local thyroid gland radiation dose and its correlations with incidence of HT.
Our study aim the changes in thyroid volume of breast cancer patients who received RT to the SCV nodal area, to evaluate RT-induced thyroid gland evolution based on local radiation dose. We then assessed the association between thyroid volume changes and the incidence of post-RT Hypothyrodism in breast cancer patients.
the aim of the study to diagnose subclinical hypothyroidism and biochemical changes in thyroid function after radiotherapy for breast cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brest cancer | – | –breast cancer patients who will be indicated for postoperative ( mastectomy /BCT) adjuvant radiotherapy who are>18 yrs old breast cancer ( pathological proved ) Stage II/III breast cancer High risk local recurrence ( LVI/ G3/ LN positive) Non metastatic breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer patients who will be indicated for postoperative ( mastectomy /BCT) adjuvant radiotherapy
Key inclusion criteria (4 listed)
- >18 yrs old breast cancer ( pathological proved )
- Stage II/III breast cancer
- High risk local recurrence ( LVI/ G3/ LN positive)
- Non metastatic breast cancer
Key exclusion criteria (1 listed)
- Thyriod dysfunction of any othe cause( no known pretreatment primary thyroid disease or dysfunction; no prior thyroid surgery; and no prior RT that involved the hypothalamic-pituitary axis or thyroid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of subclinical hypothyroidism
Time frame: 3 months
subclinical hypothyroidism after radiotherapy for breast cancer
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 11 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Brest Cancer, run by Assiut University.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
incidence of subclinical hypothyroidism (time frame: 3 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 11 Feb 2025.