Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer
19 novembre 2018 mis à jour par: 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Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times.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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times.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The total amount of blood withdrawn during the study will be approximately 9 teaspoons.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.
Type d'étude
Observationnel
Inscription (Réel)
40
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest Baptist Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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.
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|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC
Délai: up to 12 months
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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
Délai: up to 12 months
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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.
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up to 12 months
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Change in ctDNA by treatment group
Délai: up to 12 months
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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.
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up to 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Health Related Quality of Life- (HRQL)
Délai: 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
Délai: up to 12 months
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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
Délai: up to 12 months
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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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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- Anker P, Mulcahy H, Chen XQ, Stroun M. Detection of circulating tumour DNA in the blood (plasma/serum) of cancer patients. Cancer Metastasis Rev. 1999;18(1):65-73. doi: 10.1023/a:1006260319913.
- Sorenson GD, Pribish DM, Valone FH, Memoli VA, Bzik DJ, Yao SL. Soluble normal and mutated DNA sequences from single-copy genes in human blood. Cancer Epidemiol Biomarkers Prev. 1994 Jan-Feb;3(1):67-71.
- Minamoto T, Yamashita N, Ochiai A, Mai M, Sugimura T, Ronai Z, Esumi H. Mutant K-ras in apparently normal mucosa of colorectal cancer patients. Its potential as a biomarker of colorectal tumorigenesis. Cancer. 1995 Mar 15;75(6 Suppl):1520-6. doi: 10.1002/1097-0142(19950315)75:6+3.0.co;2-l.
- Sorenson GD. Detection of mutated KRAS2 sequences as tumor markers in plasma/serum of patients with gastrointestinal cancer. Clin Cancer Res. 2000 Jun;6(6):2129-37.
- Sorenson GD. A review of studies on the detection of mutated KRAS2 sequences as tumor markers in plasma/serum of patients with gastrointestinal cancer. Ann N Y Acad Sci. 2000 Apr;906:13-6. doi: 10.1111/j.1749-6632.2000.tb06582.x. No abstract available.
- Kirk GD, Camus-Randon AM, Mendy M, Goedert JJ, Merle P, Trepo C, Brechot C, Hainaut P, Montesano R. Ser-249 p53 mutations in plasma DNA of patients with hepatocellular carcinoma from The Gambia. J Natl Cancer Inst. 2000 Jan 19;92(2):148-53. doi: 10.1093/jnci/92.2.148.
- Jackson PE, Qian GS, Friesen MD, Zhu YR, Lu P, Wang JB, Wu Y, Kensler TW, Vogelstein B, Groopman JD. Specific p53 mutations detected in plasma and tumors of hepatocellular carcinoma patients by electrospray ionization mass spectrometry. Cancer Res. 2001 Jan 1;61(1):33-5.
- Shao ZM, Wu J, Shen ZZ, Nguyen M. p53 mutation in plasma DNA and its prognostic value in breast cancer patients. Clin Cancer Res. 2001 Aug;7(8):2222-7.
- Silva JM, Gonzalez R, Dominguez G, Garcia JM, Espana P, Bonilla F. TP53 gene mutations in plasma DNA of cancer patients. Genes Chromosomes Cancer. 1999 Feb;24(2):160-1.
- Mayall F, Jacobson G, Wilkins R, Chang B. Mutations of p53 gene can be detected in the plasma of patients with large bowel carcinoma. J Clin Pathol. 1998 Aug;51(8):611-3. doi: 10.1136/jcp.51.8.611.
- Bruhn N, Beinert T, Oehm C, Jandrig B, Petersen I, Chen XQ, Possinger K, Fleischhacker M. Detection of microsatellite alterations in the DNA isolated from tumor cells and from plasma DNA of patients with lung cancer. Ann N Y Acad Sci. 2000 Apr;906:72-82. doi: 10.1111/j.1749-6632.2000.tb06594.x.
- Chen XQ, Stroun M, Magnenat JL, Nicod LP, Kurt AM, Lyautey J, Lederrey C, Anker P. Microsatellite alterations in plasma DNA of small cell lung cancer patients. Nat Med. 1996 Sep;2(9):1033-5. doi: 10.1038/nm0996-1033.
- Gonzalez R, Silva JM, Sanchez A, Dominguez G, Garcia JM, Chen XQ, Stroun M, Provencio M, Espana P, Anker P, Bonilla F. Microsatellite alterations and TP53 mutations in plasma DNA of small-cell lung cancer patients: follow-up study and prognostic significance. Ann Oncol. 2000 Sep;11(9):1097-104. doi: 10.1023/a:1008305412635.
- Nawroz H, Koch W, Anker P, Stroun M, Sidransky D. Microsatellite alterations in serum DNA of head and neck cancer patients. Nat Med. 1996 Sep;2(9):1035-7. doi: 10.1038/nm0996-1035.
- Taback B, Giuliano AE, Hansen NM, Hoon DS. Microsatellite alterations detected in the serum of early stage breast cancer patients. Ann N Y Acad Sci. 2001 Sep;945:22-30. doi: 10.1111/j.1749-6632.2001.tb03860.x.
- Taback B, O'Day SJ, Boasberg PD, Shu S, Fournier P, Elashoff R, Wang HJ, Hoon DS. Circulating DNA microsatellites: molecular determinants of response to biochemotherapy in patients with metastatic melanoma. J Natl Cancer Inst. 2004 Jan 21;96(2):152-6. doi: 10.1093/jnci/djh011.
- Taback B, Fujiwara Y, Wang HJ, Foshag LJ, Morton DL, Hoon DS. Prognostic significance of circulating microsatellite markers in the plasma of melanoma patients. Cancer Res. 2001 Aug 1;61(15):5723-6.
- Goessl C, Heicappell R, Munker R, Anker P, Stroun M, Krause H, Muller M, Miller K. Microsatellite analysis of plasma DNA from patients with clear cell renal carcinoma. Cancer Res. 1998 Oct 15;58(20):4728-32.
- Muller HM, Widschwendter M. Methylated DNA as a possible screening marker for neoplastic disease in several body fluids. Expert Rev Mol Diagn. 2003 Jul;3(4):443-58. doi: 10.1586/14737159.3.4.443.
- Collisson E, Mortimer S, Sebisanovic D, et al. Biopsy-free comprehensive tumor profiling of 1,000+ consecutive cancer patients using CLIA-certified commercial test and its clinical utility. Paper presented at: 2015 AACR Annual Meeting. Abstract #2403. 2015.
- Talasaz A, Mortimer S, Sebisanovic D, et al. Use of the GUARDANT360 noninvasive tumor sequencing assay on 300 patients across colorectal, melanoma, lung, breast, and prostate cancers and its clinical utility. J Clin Oncol 32, 2014 (suppl; abstr e22041).
- Austin LK, Avery T, Jaslow R, et al. Concordance of circulating tumor DNA (ctDNA) and next-generation sequencing (NGS) as molecular monitoring tools in metastatic breast cancer (MBC). Paper presented at: 2015 AACR Annual Meeting. Abstract #4918. 2015.
- Austin LK, Jaslow R, Avery T, et al. Clinical utility of circulating tumor DNA (ctDNA) in advanced and metastatic breast cancer. Paper presented at: 2015 AACR Annual Meeting. Abstract #4928. 2015.
- Piccioni DE, Lanman RB, Nagy RJ, Talasaz A, Pingle SC, Kesari S. Analysis of cell-free circulating tumor DNA in patients with glioblastoma and other primary brain tumors. Paper presented at: 2015 ASCO Annual Meeting. J Clin Oncol 33, 2015 (suppl; abstr 11072). 2015.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
13 mai 2016
Achèvement primaire (Réel)
10 août 2018
Achèvement de l'étude (Réel)
10 août 2018
Dates d'inscription aux études
Première soumission
12 novembre 2018
Première soumission répondant aux critères de contrôle qualité
16 novembre 2018
Première publication (Réel)
19 novembre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 novembre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 novembre 2018
Dernière vérification
1 novembre 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00036520
- P30CA012197 (Subvention/contrat des NIH des États-Unis)
- CCCWFU 62A15 (Autre identifiant: NCI)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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