Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer
19 ноября 2018 г. обновлено: Wake Forest University Health Sciences
A Pilot Study of Changes in Circulating Tumor-Specific DNA (ctDNA) in Patients With Non-Metastatic Non-Small Cell Lung Cancer
The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA).
It is hypothesized that ctDNA may identify patients who can be considered for additional therapy.
40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study.
Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times.
These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA).
It is hypothesized that ctDNA may identify patients who can be considered for additional therapy.
40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study.
Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times.
These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment.
The total amount of blood withdrawn during the study will be approximately 9 teaspoons.
Participants will be followed every 3 months for 12 months to determine if a confirmed recurrence or progression has occurred.
Participants will also be asked to complete questionnaires on their quality of life and their smoking behaviors.
As part of this study, a blood sample will be obtained and DNA from participants blood sample will be purified.
DNA, or deoxyribonucleic acid, stores and transmits inherited traits, such as eye color or blood type.
As part of this research project, participant's DNA will be studied in an effort to find out if there are genes that contribute to medical conditions like their cancer that are part of the study.
If participants have surgery to have tumor removed or if participants have a biopsy of their tumor, the study would like to take some of the leftover tissue to purify and study the DNA from the tissue sample.
Тип исследования
Наблюдательный
Регистрация (Действительный)
40
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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North Carolina
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Winston-Salem, North Carolina, Соединенные Штаты, 27157
- Wake Forest Baptist Medical Center
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Метод выборки
Невероятностная выборка
Исследуемая популяция
Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.
Описание
Inclusion Criteria:
- Patients with histologically confirmed or clinically suspected stage I, II or III NSCLC, provided such patients will be scheduled for a procedure that will provide histologic confirmation of the diagnosis (if the procedure does not provide histologic confirmation of the diagnosis of NSCLC the particular patient will be removed from the study and replaced).
- Scheduled for treatment with surgery or radiotherapy (Stage I), surgery and chemotherapy (Stage II), or chemoradiotherapy (Stage III). For stage I receiving radiotherapy, treatment must be stereotactic body radiation therapy (SBRT) consisting of 3-5 fractions.
- Ability to provide blood sample at the following time points: pre-treatment, 1 month post definitive treatment, and 4 post definitive treatment.
- Ability to understand and the willingness to sign an IRB-approved informed consent document.
- Staging studies including PET-CT for all patients prior to the initiation of primary treatment, as a pretreatment requirement. For patients with Stage II and III, MRI or CT of the brain is needed prior to the initiation of primary treatment. Patients, however, may be registered and have the pretreatment blood sample collected, provided that the staging studies are being scheduled. Registered patients who are found, after screening tests, to have Stage IV disease will be removed from the study and replaced.
Exclusion Criteria:
- Females who are pregnant
- History of organ transplant.
- For stage II and III patients, must be able to receive chemotherapy.
- Active cardiovascular issues in the past 6 months.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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Patients - Stage I treated with surgery
ctDNA measures will be taken and descriptive statistics will be estimated.
These include means, standard deviations, and 95% confidence intervals.
Next, within group changes in ctDNA levels will be measured for each of the four groups.
These change values will be estimated with 95% confidence intervals.
In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up.
After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.
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|
Patients - Stage I treated with radiotherapy
ctDNA measures will be taken and descriptive statistics will be estimated.
These include means, standard deviations and 95% confidence intervals.
Next, within group changes in ctDNA levels will be measured for each of the four groups.
These change values will be estimated with 95% confidence intervals.
In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up.
After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.
|
|
Patients - Stage II treated with surgery & chemotherapy
ctDNA measures will be taken and descriptive statistics will be estimated.
These include means, standard deviations and 95% confidence intervals.
Next, within group changes in ctDNA levels will be measured for each of the four groups.
These change values will be estimated with 95% confidence intervals.
In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up.
After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.
|
|
Patients - Stage III treated with chemoradiotherapy
ctDNA measures will be taken and descriptive statistics will be estimated.
These include means, standard deviations and 95% confidence intervals.
Next, within group changes in ctDNA levels will be measured for each of the four groups.
These change values will be estimated with 95% confidence intervals.
In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up.
After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC
Временное ограничение: up to 12 months
|
ctDNA levels in patients with Stage I or II NSCLC treated with surgery compared with ctDNA levels in the rest of the cohort.
Comparisons will be made at the following time points: Pre-treatment, Post-treatment, and Follow-up.
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up to 12 months
|
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Change in ctDNA levels in patients with Stage III NSCLC
Временное ограничение: up to 12 months
|
ctDNA levels in patients with Stage III NSCLC treated with chemoradiotherapy compared with ctDNA levels in the rest of the cohort.
Comparisons will be made at the following time points: Pre-treatment, Post-treatment , and Follow-up.
|
up to 12 months
|
|
Change in ctDNA by treatment group
Временное ограничение: up to 12 months
|
To determine the change in ctDNA by treatment group at the following time points: change from Pre-treatment to Post-treatment, and change from Pre-treatment to Follow-up.
|
up to 12 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Health Related Quality of Life- (HRQL)
Временное ограничение: up to 12 months
|
A two part questionnaire, will be used to assess HRQL: (1) QLQ-C30, a core questionnaire covering general aspects of HRQL, and (2) QLQ-LC13, a lung cancer specific questionnaire.
For the QLQ-C30 - All of the scales and single-item measures range in score from 0 to 100.
A high scale score represents a higher response level.
For the QLQ-LC13 - All of the scales and single-item measures range in score from 0 to 100.
A high score for the scales and single items represents a high level of symptomatology or problems.
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up to 12 months
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Number of Packs Smoked Per Day
Временное ограничение: up to 12 months
|
The number of packs of tobacco participants smoked per day will be assessed and recorded
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up to 12 months
|
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Number of Years Smoked
Временное ограничение: up to 12 months
|
The number of years participants smoked will be recorded.
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up to 12 months
|
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Number of Participants that have a Smoking Status
Временное ограничение: up to 12 months
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Participants will be asked about their current smoking status (yes/no).
These answers will be recorded.
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up to 12 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
13 мая 2016 г.
Первичное завершение (Действительный)
10 августа 2018 г.
Завершение исследования (Действительный)
10 августа 2018 г.
Даты регистрации исследования
Первый отправленный
12 ноября 2018 г.
Впервые представлено, что соответствует критериям контроля качества
16 ноября 2018 г.
Первый опубликованный (Действительный)
19 ноября 2018 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
21 ноября 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
19 ноября 2018 г.
Последняя проверка
1 ноября 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB00036520
- P30CA012197 (Грант/контракт NIH США)
- CCCWFU 62A15 (Другой идентификатор: NCI)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .