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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| CCCWFU 62A15 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| Guardant Health, Inc. | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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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 Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times.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 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 Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times.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 The total amount of blood withdrawn during the study will be approximately 9 teaspoons.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life- (HRQL) | 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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Inclusion Criteria:
Exclusion Criteria:
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Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Grant, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10505546 | Background | 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. | |
| 8118388 | Background | 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. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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whole blood and tissue when available
| 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. |
| up to 12 months |
| Number of Packs Smoked Per Day | The number of packs of tobacco participants smoked per day will be assessed and recorded | up to 12 months |
| Number of Years Smoked | The number of years participants smoked will be recorded. | up to 12 months |
| Number of Participants that have a Smoking Status | Participants will be asked about their current smoking status (yes/no). These answers will be recorded. | up to 12 months |
| 7889485 | Background | 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. |
| 10873061 | Background | 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. |
| 10818588 | Background | 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. |
| 10639517 | Background | 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. |
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| 11489795 | Background | 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. |
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| 9885984 | Background | 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. |
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| 10818600 | Background | 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. |
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| 11708482 | Background | 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. |
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| Background | 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. |
| Background | 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). |
| Background | 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. |
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| Background | 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. |
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| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |