Non Small Cell Lung CancerNCT03746262
Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2016to 10 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non-Metastatic Non-Small Cell Lung Cancer, Cancer, Lung Cancer, circulating tumor-specific DNA (ctDNA), non-invasive diagnostic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms, Lung Neoplasms
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 12 months
Secondary outcomes (4)
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.
Measured: 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
Measured: up to 12 months
Number of Years Smoked
The number of years participants smoked will be recorded.
Measured: 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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start13 May 2016
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Guardant Health, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stefan Grant, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746262
- Sponsor's protocol ID
- IRB00036520
- Other IDs
- P30CA012197, CCCWFU 62A15
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10505546Sorenson 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.
PubMed 8118388Minamoto 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.
PubMed 7889485Sorenson 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.
PubMed 10873061Sorenson 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.
PubMed 10818588Kirk 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.
PubMed 10639517Jackson 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.
PubMed 11196182Shao 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.
PubMed 11489795Silva 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.
PubMed 9885984Mayall 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.
PubMed 9828821Bruhn 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.
PubMed 10818600Chen 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.
PubMed 8782463Gonzalez 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.
PubMed 11061602Nawroz 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.
PubMed 8782464Taback 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.
PubMed 11708482
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Changes in Circulating Tumor-Specific DNA (ctDNA) in Patients With Non-Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03746262
- Acronym / sponsor ID
- IRB00036520
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non-Metastatic Non-Small Cell Lung Cancer, Cancer, Lung Cancer, circulating tumor-specific DNA (ctDNA), non-invasive diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Guardant Health, Inc., National Cancer Institute (NCI)
- Study start
- 13 May 2016 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 19 Nov 2018 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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
Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC
Time frame: 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.
Change in ctDNA levels in patients with Stage III NSCLC
Time frame: 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.
Change in ctDNA by treatment group
Time frame: 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.
4 secondary outcomes
Health Related Quality of Life- (HRQL)
Time frame: up to 12 months
Number of Packs Smoked Per Day
Time frame: up to 12 months
Number of Years Smoked
Time frame: up to 12 months
Number of Participants that have a Smoking Status
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Background: PubMed 10505546Anker 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.
- Background: PubMed 8118388Sorenson 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.
- Background: PubMed 7889485Minamoto 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.
- Background: PubMed 10873061Sorenson 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.
- Background: PubMed 10818588Sorenson 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.
- Background: PubMed 10639517Kirk 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.
- Background: PubMed 11196182Jackson 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.
- Background: PubMed 11489795Shao 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.
- Background: PubMed 9885984Silva 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.
- Background: PubMed 9828821Mayall 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.
- Background: PubMed 10818600Bruhn 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.
- Background: PubMed 8782463Chen 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stefan Grant, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC (time frame: up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746262, which also lists 25 linked publications.
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 21 Nov 2018.