NCT04110223

Brief Summary

Despite the common application of radiotherapy in cancer treatment, the prediction of radiosensitivity and treatment response has not yet entered the era of precision medicine. Therefore, development of genome-based methods for predicting radiosensitivity and treatment response is a central goal of radiation oncology. In the previous study, the investigators have identified a set of novel potential biomarkers associated with radiosensitivity and recurrence，through correlating patients' genomic profiles with toxicity, disease progression and overall survival after RT.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

June 12, 2019

Last Update Submit

September 29, 2019

Conditions

Radiation ToxicityAdvanced CancerRadiosensitivity

Keywords

radiotherapyradiosensitivityradiation toxityNGS

Outcome Measures

Primary Outcomes (2)

  • TTP

    Time to progression

    2 years

  • OS

    Time to death

    2 years

Study Arms (6)

non-smell cell lung cancer (NSCLC)

Advanced NSCLC patients receiving radiotherapy or chemo-radiotherapy

Genetic: next generation sequence

Rectal cancer

Rectal cancer patients receiving neoadjuvant radiotherapy or chemo-radiotherapy

Genetic: next generation sequence

Smell cell lung cancer (SCLC)

SCLC patients receiving radiotherapy or chemo-radiotherapy

Genetic: next generation sequence

Esophageal cancer

Esophageal cancer patients receiving radiotherapy or chemo-radiotherapy

Genetic: next generation sequence

Cervical cancer

Cervical cancer patients receiving radiotherapy or chemo-radiotherapy

Genetic: next generation sequence

Liver cancer

Liver cancer atients receiving radiotherapy or chemo-radiotherapy

Genetic: next generation sequence

Interventions

next generation sequenceGENETIC

targeted NGS of patients' pretreatment tumor biopsy samples using a 474-gene panel, which covers cancer- and radio-sensitivity-related mutations and SNPs.

Cervical cancerEsophageal cancerLiver cancerRectal cancerSmell cell lung cancer (SCLC)non-smell cell lung cancer (NSCLC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in the study with locally advanced solid tumors undergoing conventional fractionation or preoperative neoadjuvant radiotherapy (except stage IV patients and stage I patients to be treated with SBRT), including lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma and liver cancer

You may qualify if:

  • Patients with locally advanced solid tumors (lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma cancer and liver cancer) identified by cytology and pathology;
  • Patients need conventional fractionation and adequate radiotherapy;
  • Age ≥ 18 years old, male and female;
  • Expected survival time ≥ 12 weeks;
  • PS score 0-2 within 2 weeks before admission to the group;
  • There are tumor tissue samples and blood samples can be used for NGS inspection;
  • Patients volunteered to join this study, sign informed consent, provide all diagnosis and treatment data after cancer diagnosis before entering the group, good compliance, cooperate with follow-up.

You may not qualify if:

  • The patient's previous radiation therapy leads to overlapping potential fields;
  • Stage IV patients and stage I patients to be treated with SBRT
  • The patient cannot receive regular imaging examinations;
  • Any serious or uncontrolled signs of systemic disease that the investigator believes may significantly affect the patient's risk/benefit balance, including hepatitis B, hepatitis C, and human immunodeficiency virus;
  • The researcher believes that it is not suitable for the group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor biopsy samples

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jinming Yu, Ph.D

    Shandong Cancer Hospital and Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuanghu Yuan Ph.D

CONTACT

+8613853106916yuanshuanghu@sina.com

Yong M Shao, Ph.D

CONTACT

025-58461736yang.shao@geneseeq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

June 12, 2019

First Posted

October 1, 2019

Study Start

October 8, 2018

Primary Completion

October 8, 2021

Study Completion

October 8, 2021

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)