Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Axitinib

Immunomodulating Agents

Sunitinib

Immune Checkpoint Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Programmed death-ligand 1 Inhibitor combined with axitinib

sunitinib or pazopanib

targeted therapy combined with immunotherapy

PD-1 inhibitor combined with axitinib

wei xue

jiwei huang, M.D

wei xue, M.D

Next-Generation Sequencing and whole transcriptome RNA sequencing were used to detect genomic variation and expression in tissues or blood, respectively. The treatment outcome of single targeted therapy or combined with immunotherapy was observed and followed up. Through this study, we intend to achieve RNA molecular classification of Chinese mRCC patients and to evaluate the correlation between ctDNA level, RNA molecular classification and treatment outcome, provide reference for metastatic RCC precise diagnosis and treatment.

Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma

A Prospective Observational Study of Molecular Classification and Circulating Tumor DNA Dynamic Monitoring to Explore Related Factors That Predict the Efficacy of Single Targeted Therapy or Combined With Immunotherapy for Metastatic Renal Cell Carcinoma

Ruijin Hospital

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

West China Hospital

Xiangya Hospital of Central South University

Fudan University

Second Affiliated Hospital, School of Medicine, Zhejiang University

Second Affiliated Hospital of Nantong University

Peking University First Hospital

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Zhejiang University

First Affiliated Hospital of Wenzhou Medical University

Sir Run Run Shaw Hospital

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

The General Hospital of Eastern Theater Command

The First Affiliated Hospital with Nanjing Medical University

The First Affiliated Hospital of University of Science and Technology of China

The Second Hospital of Anhui Medical University

Tongji Hospital

The First Affiliated Hospital of Zhengzhou University

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Peking Union Medical College Hospital

The First Affiliated Hospital of Shanxi Medical University

Shanxi Provincial Cancer Hospital

Changzhi Medical College

First Affiliated Hospital Xi'an Jiaotong University

Second Affiliated Hospital of Xi'an Jiaotong University

Xijing Hospital of Air Force Military Medical University

Tang-Du Hospital

Quanzhou First Hospital Affiliated to Fujian Medical University

Third Affiliated Hospital, Sun Yat-Sen University

RenJi Hospital

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

ctDNA is detected before operation, before chemotherapy, and then every three months for 2 years, 10 times in total. At the same time, routine postoperative follow-up is given.

To be pointed out, after the completion of the adjuvant chemotherapy, if the ctDNA test indicates positive, patients will immediately perform chest, abdominal and pelvic CT and other imaging tests to determine whether there is recurrence /metastasis. If it is not confirmed, repeat the imaging review every two months, and continue to perform ctDNA test every three months. If the following ctDNA test is negative for two consecutive times, the above imaging reexamination will return to the routine follow-up frequency. In addition, during the follow-up, the following situations may occur: the imaging examination has found recurrence/metastasis, but the ctDNA test is still negative. At this time, the patient will be informed and treated in time of the recurrence/metastasis.

Only routine postoperative follow-up is given as follows: Physical examination and CEA were performed every 3-6 months for the first 2 years, every 6 months within the third to fifth year, and then annually. Chest/abdominal/pelvis computed tomography was performed annually for up to 5 years, and colonoscopy was performed for proper patients the first year after treatment and repeated in the third year if no advanced adenoma was found and then every 5 years.

ctDNA is detected before operation, before chemotherapy, and then every three months for 2 years, 10 times in total.

ctDNA dynamic monitoring

Junjie Peng, MD, PhD

Yaqi Li

Yaqi Li, MD, PhD

For patients with stage III colon cancers, radical resection of primary tumor followed by adjuvant chemotherapy is currently the standard treatment. Adjuvant chemotherapy with 5-fluorouracil and oxaliplatin based regimen has been proved effective to improve recurrence-free survival and overall survival. Approximately half of patients with stage III colon cancers can be cured by surgery alone, while a substantial number of patients still experience recurrence, even with standard adjuvant chemotherapy. In recent years, circulating tumor DNA (ctDNA) has been detected in the cell-free component of peripheral blood samples in advanced colorectal cancers and many other solid tumors. Several previous studies have suggested that in patients with stage I-III colorectal cancer, postoperative ctDNA was an valuable biomarker to predict minimal residual disease (MRD) after radical resection, thus redefining patients risk outcome groups and guiding postoperative treatment. In addition, recent studies based on serial postoperative ctDNA detection showed that serial ctDNA analyses revealed disease recurrence up to 5-16.5 months ahead of radiological imaging. Here, based on the role of ctDNA in predicting MRD, we conducted an open, prospective, randomized controlled phase II cohort study to explore if ctDNA can as a biomarker to guide personalized surveillance strategy after surgery.

Postoperative adjuvant therapy (chemotherapy and radiotherapy) and specific implementation scheme shall be determined by the clinical physician blinded to ctDNA status and randomized group. Other parts are open-label.

Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study

Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis

Number of patients with ctDNA negative and no recurrence and metastasis confirmed by imaging / number of patients with no recurrence and metastasis confirmed by imaging

The rate of R0 resection for recurrence or metastasis after surgery of the primary

Disease free survival time under ctDNA monitoring

Disease free survival time under imaging monitoring

The difference between ctDNA-DFS and CT-DFS

The rate of ctDNA positive before chemotherapy that turns negative after adjuvant chemotherapy

Department of Colorectal Surgery，Fudan University Shanghai Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma	NCT05816642	Metastatic Rena...	sunitinib or pa... PD-1 inhibitor ...	-	RenJi Hospital
Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study	NCT05161585	Stage III Color... Circulating Tum...	ctDNA dynamic m...	18 Years - 80 Years	Fudan University
Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study	NCT05161585	Stage III Color... Circulating Tum...	ctDNA dynamic m...	18 Years - 80 Years	Fudan University

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