Monitoring Efficacy of Radiotherapy in Lung Cancer and Esophageal Cancer

NCT ID: NCT04014465

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-12-01

Brief Summary

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Lung cancer, one of the malignant tumors which poses a threat to human's health, has increased morbidity and mortality recently. Radiotherapy, as one of the common treatments, has important value in clinical application. Esophageal cancer, one of the most common digestive system cancers, has poor prognosis and high mortality. Esophageal cancer has high aggressive and many patients can't get surgical treatment because of the tumor metastasis at the time of diagnosis.Currently, chemoradiotherapy has become one of the standard treatment regimens for patients with unresectable esophageal cancer in National Comprehensive Cancer Network(NCCN). So radiotherapy is one of the most important treatments in esophageal cancer.

Currently, the efficacy evaluation method of radiotherapy is by imaging examination after several courses of treatment. However, new reports suggest that circulating tumor DNA(ctDNA) has the potential to be an indicator of therapeutic effectiveness and recurrence risk.

Detailed Description

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Circulating free DNA (cfDNA) can be found dissolved in plasma and serum, at variable amounts. In the case of cancer patients, ctDNA is a fraction of the cfDNA derived from tumor. Currently, the ctDNA is widely used in "liquid biopsy" for not only does it carry the same somatic alterations as the tumor itself but also its percentage is correlated with tumor burden.

This study will investigate the clinical value of efficacy evaluation and prognosis of ctDNA detecting technique in patients with radiotherapy.

Conditions

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Lung Cancer Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with radiotherapy

The patients of lung cancer or esophagueal cancer, who received definitvie RT, should included in this Cohort.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with histopathological proved lung cancer or esophageal cancer.
* Candidate for radiotherapy.
* No history of prior anti-tumor treatment.
* Eastern Cooperative Oncology Group (ECOG) score 0,1.
* Being able to receive computed tomography (CT) and magnetic resonance imaging (MRI).
* Blood sample is available for dynamic monitoring.
* Written informed consent provided.
* Good compliance in the follow-up.

Exclusion Criteria

* Had received radiotherapy, chemotherapy, biotherapy or other treatment that is related to lung cancer or esophageal cancer.
* The patients have the sign of any serious or uncontrolled systematic diseases that may have significant impact on the balance between risk and benefit, such as hypertension, infection of hepatitis B, hepatitis C or human immunodeficiency virus(HIV).
* With history of alcohol or drug abuse.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tao Zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nan Bi, Doctor

Role: CONTACT

8613520445135

Tao Zhang, Professor

Role: CONTACT

8618911006677

Facility Contacts

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Department of Radiation Oncology

Role: primary

References

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Chen W, Zheng R, Zhang S, Zeng H, Zuo T, Xia C, Yang Z, He J. Cancer incidence and mortality in China in 2013: an analysis based on urbanization level. Chin J Cancer Res. 2017 Feb;29(1):1-10. doi: 10.21147/j.issn.1000-9604.2017.01.01.

Reference Type RESULT
PMID: 28373748 (View on PubMed)

Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

Reference Type RESULT
PMID: 25651787 (View on PubMed)

Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92. doi: 10.1200/JCO.2007.12.9593.

Reference Type RESULT
PMID: 18309943 (View on PubMed)

Rolfo C, Castiglia M, Hong D, Alessandro R, Mertens I, Baggerman G, Zwaenepoel K, Gil-Bazo I, Passiglia F, Carreca AP, Taverna S, Vento R, Santini D, Peeters M, Russo A, Pauwels P. Liquid biopsies in lung cancer: the new ambrosia of researchers. Biochim Biophys Acta. 2014 Dec;1846(2):539-46. doi: 10.1016/j.bbcan.2014.10.001. Epub 2014 Oct 16.

Reference Type RESULT
PMID: 25444714 (View on PubMed)

Newman AM, Bratman SV, To J, Wynne JF, Eclov NC, Modlin LA, Liu CL, Neal JW, Wakelee HA, Merritt RE, Shrager JB, Loo BW Jr, Alizadeh AA, Diehn M. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med. 2014 May;20(5):548-54. doi: 10.1038/nm.3519. Epub 2014 Apr 6.

Reference Type RESULT
PMID: 24705333 (View on PubMed)

Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Quinn AM, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG, Swanton C. Corrigendum: Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2018 Feb 8;554(7691):264. doi: 10.1038/nature25161. Epub 2017 Dec 20.

Reference Type RESULT
PMID: 29258292 (View on PubMed)

Wu Y, Li C, Yang Y, Zhang T, Wang J, Tang W, Li N, Bao H, Wang X, Bi N. Predicting Disease Progression in Inoperable Localized NSCLC Patients Using ctDNA Machine Learning Model. Cancer Med. 2024 Oct;13(20):e70316. doi: 10.1002/cam4.70316.

Reference Type DERIVED
PMID: 39445439 (View on PubMed)

Other Identifiers

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NCC1923

Identifier Type: -

Identifier Source: org_study_id

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