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Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer

19 listopada 2018 zaktualizowane przez: 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 Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times.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.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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 Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times.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 The total amount of blood withdrawn during the study will be approximately 9 teaspoons.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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

40

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • North Carolina
      • Winston-Salem, North Carolina, Stany Zjednoczone, 27157
        • Wake Forest Baptist Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC
Ramy czasowe: 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.
up to 12 months
Change in ctDNA levels in patients with Stage III NSCLC
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Health Related Quality of Life- (HRQL)
Ramy czasowe: 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.
up to 12 months
Number of Packs Smoked Per Day
Ramy czasowe: up to 12 months
The number of packs of tobacco participants smoked per day will be assessed and recorded
up to 12 months
Number of Years Smoked
Ramy czasowe: up to 12 months
The number of years participants smoked will be recorded.
up to 12 months
Number of Participants that have a Smoking Status
Ramy czasowe: up to 12 months
Participants will be asked about their current smoking status (yes/no). These answers will be recorded.
up to 12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Wake Forest University Health Sciences

Współpracownicy

National Cancer Institute (NCI)
Guardant Health, Inc.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 maja 2016

Zakończenie podstawowe (Rzeczywisty)

10 sierpnia 2018

Ukończenie studiów (Rzeczywisty)

10 sierpnia 2018

Daty rejestracji na studia

Pierwszy przesłany

12 listopada 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 listopada 2018

Pierwszy wysłany (Rzeczywisty)

19 listopada 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 listopada 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 listopada 2018

Ostatnia weryfikacja

1 listopada 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB00036520
  • P30CA012197 (Grant/umowa NIH USA)
  • CCCWFU 62A15 (Inny identyfikator: NCI)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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