LymphomaNCT04062877
Clinical Application of Liquid Biopsy for Precise Diagnosis and Prognosis in Lymphoma
An observational study of Lymphoma, run by Ge Zheng at 1 site in China.
Trial summary
Lymphoma is a highly heterogeneous blood malignancy. It is very important to search for relative specific diagnostic markers that can detect related lymphoma in early stage for the treatment and long-term prognosis of the disease, as the hematopoietic diseases, such as lymphoma, are more difficult to biopsy than solid… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 30 Dec 2021
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients of lymphoma diagnosed of de novo, CR, relapsed/refractory, be willing to receive treatment, aged between 14 to 75 years.
Who may be able to join
- patients of lymphoma diagnosed of de novo, CR, relapsed/refractory, be willing to receive treatment
Who cannot join
- leukemia
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology Southeast University Department of Hematology Zhongda Hospital Southeast University Medical School
Nanjing, Jiangsu, 210000
About this study
Official title: Clinical Transformation Application and Technology Research in Liquid Biopsy for Precise Diagnosis and Prognosis of Lymphoma
Lymphoma is a highly heterogeneous blood malignancy. It is very important to search for relative specific diagnostic markers that can detect related lymphoma in early stage for the treatment and long-term prognosis of the disease, as the hematopoietic diseases, such as lymphoma, are more difficult to biopsy than solid tumors, with more damage and side effects.Liquid Biopsy (Liquid Biopsy) refers to the extraction of solid biological tissue, is the most common blood, also including saliva, urine, cerebrospinal fluid and other body fluids, and extract the circulating tumor cells (circulating tumor cell, CTC) and circulating tumor DNA (circulating tumor DNA, ctDNA) is used to assess related diseases. CTCs/CSCs have the ability to generate new tumors and play a key role in tumor metastasis.This project intends to develop liquid biopsy technology for accurate diagnosis and prognosis judgment of lymphoma, to carry out clinical transformation application and serve patients.
Read the detailed description
- Patients with series and matched lymphoma who were refractory to initial diagnosis, remission and recurrence were enrolled, our research group will collected patient information comprehensively and signed the informed consent.
- The standard diagnosis process and treatment selection will be completed, and our research group willcollect relevant clinical and laboratory data.
- 5 ml of peripheral blood from each patient was collected with EDTA anticoagulant tube, and the blood cells were centrifuged at 820×g for 10 min at 4℃ within 1 h to separate the blood cells.The plasma was then transferred to a microcentrifuge tube and centrifuged at 4℃ at 20,000×g for 10 min to remove cell debris.According to the reagent instructions, cfDNA was extracted from 2 ml cell-free plasma and the concentration of cfDNA in each patient was determined.Meanwhile, genomic DNA kit was used to extract matching tumor DNA from lymphoma bone marrow tissue.
- We will extract the lymphoma of bone marrow tissue samples of RNA, and reverse transcription for cDNA, the use of qRT PCR verifying the mutations in tissue samples, after identifying the lymphoma five of the most common mutations from the cancer genome map (TCGA;http://cancergenome.nih.gov/) .
- The differences of mutations detected by liquid biopsy and tumor in situ biopsy will be compared, by NGS sequencing of peripheral blood cfDNA and lymphoma tissue DNA. Meanwhile, the mutation rate of each gene mutation was analyzed for lymphoma tissue type.
- The classification and malignant changes of matched lymphomas were statistically analyzed to study the differences in cfDNA concentration of different types of lymphomas, according to the cfDNA concentration determined at the earlier stage.
- The mutation differences of cfDNA in the peripheral blood of each patient will be compared at three time points before, during and after treatment, combined with PET/CT detection, and the correlation between cfDNA detection indexes and therapeutic effect and prognosis monitoring will be evaluated.
- SPSS 23.0 statistical software would be used to evaluate the correlation between cfDNA concentration in lymphoma and disease staging, grouping, subtype, efficacy prediction and recurrence monitoring. P<0.05 was considered statistically significant.
- Conditions
- Lymphoma
- Keywords
- Fluid biopsy, lymphoma, accurate diagnosis
- Medical subject headings
- Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission
Patients achieve complete remission after initial treatment
Measured: From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks
relapse
Patients' disease progress after complete remission
Measured: From date of randomization or complete remission until the date of first documented relapse from any cause，assessed up to 100weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Jul 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ge Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ge Zheng, Zhongda Hospital
- Investigators
- Zheng Ge, Study director, Director of Department of Hematology Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062877
- Sponsor's protocol ID
- ZDYYGZ201907
- Status last verified
- Mar 2022
- First submitted
- 5 Aug 2019
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Transformation Application and Technology Research in Liquid Biopsy for Precise Diagnosis and Prognosis of Lymphoma
- ClinicalTrials.gov ID
- NCT04062877
- Acronym / sponsor ID
- ZDYYGZ201907
- Conditions
- Lymphoma
- Keywords
- Fluid biopsy, lymphoma, accurate diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ge ZhengUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 20 Aug 2019 (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.
Lymphoma is a highly heterogeneous blood malignancy. It is very important to search for relative specific diagnostic markers that can detect related lymphoma in early stage for the treatment and long-term prognosis of the disease, as the hematopoietic diseases, such as lymphoma, are more difficult to biopsy than solid tumors, with more damage and side effects.Liquid Biopsy (Liquid Biopsy) refers to the extraction of solid biological tissue, is the most common blood, also including saliva, urine, cerebrospinal fluid and other body fluids, and extract the circulating tumor cells (circulating tumor cell, CTC) and circulating tumor DNA (circulating tumor DNA, ctDNA) is used to assess related diseases. CTCs/CSCs have the ability to generate new tumors and play a key role in tumor metastasis.This project intends to develop liquid biopsy technology for accurate diagnosis and prognosis judgment of lymphoma, to carry out clinical transformation application and serve patients.
Detailed description
- Patients with series and matched lymphoma who were refractory to initial diagnosis, remission and recurrence were enrolled, our research group will collected patient information comprehensively and signed the informed consent.
- The standard diagnosis process and treatment selection will be completed, and our research group willcollect relevant clinical and laboratory data.
- 5 ml of peripheral blood from each patient was collected with EDTA anticoagulant tube, and the blood cells were centrifuged at 820×g for 10 min at 4℃ within 1 h to separate the blood cells.The plasma was then transferred to a microcentrifuge tube and centrifuged at 4℃ at 20,000×g for 10 min to remove cell debris.According to the reagent instructions, cfDNA was extracted from 2 ml cell-free plasma and the concentration of cfDNA in each patient was determined.Meanwhile, genomic DNA kit was used to extract matching tumor DNA from lymphoma bone marrow tissue.
- We will extract the lymphoma of bone marrow tissue samples of RNA, and reverse transcription for cDNA, the use of qRT PCR verifying the mutations in tissue samples, after identifying the lymphoma five of the most common mutations from the cancer genome map (TCGA;http://cancergenome.nih.gov/) .
- The differences of mutations detected by liquid biopsy and tumor in situ biopsy will be compared, by NGS sequencing of peripheral blood cfDNA and lymphoma tissue DNA. Meanwhile, the mutation rate of each gene mutation was analyzed for lymphoma tissue type.
- The classification and malignant changes of matched lymphomas were statistically analyzed to study the differences in cfDNA concentration of different types of lymphomas, according to the cfDNA concentration determined at the earlier stage.
- The mutation differences of cfDNA in the peripheral blood of each patient will be compared at three time points before, during and after treatment, combined with PET/CT detection, and the correlation between cfDNA detection indexes and therapeutic effect and prognosis monitoring will be evaluated.
- SPSS 23.0 statistical software would be used to evaluate the correlation between cfDNA concentration in lymphoma and disease staging, grouping, subtype, efficacy prediction and recurrence monitoring. P<0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients of lymphoma diagnosed of de novo, CR, relapsed/refractory, be willing to receive treatment, aged between 14 to 75 years.
Key inclusion criteria (1 listed)
- patients of lymphoma diagnosed of de novo, CR, relapsed/refractory, be willing to receive treatment
Key exclusion criteria (1 listed)
- leukemia
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
complete remission
Time frame: From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks
Patients achieve complete remission after initial treatment
relapse
Time frame: From date of randomization or complete remission until the date of first documented relapse from any cause，assessed up to 100weeks.
Patients' disease progress after complete remission
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 24 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Zheng Ge study director
Director of Department of Hematology Zhongda Hospital
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 Lymphoma, run by Ge Zheng at 1 site in China.
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 1 inclusion and 1 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 24 Mar 2022. 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 China. 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?
complete remission (time frame: From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2022.